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Delaying antibiotics in elderly with UTI linked to higher sepsis, death rates

Older patients need prompt treatment
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Changed
Tue, 03/05/2019 - 09:35

 

Delaying or withholding antibiotics in elderly patients with a urinary tract infection (UTI) increases the risk of sepsis and death, results of a large, population-based study suggest.

andresr/Getty Images

The risk of bloodstream infection was more than seven times greater in patients who did not receive antibiotics immediately after seeing a general practitioner for a UTI versus those who did, according to results of the study based on primary care records and other data for nearly 160,000 U.K. patients aged 65 years or older. Death rates and hospital admissions were significantly higher for these patients, according to the study published in The BMJ by Myriam Gharbi, PharmD, Phd, Imperial College London, and her colleagues.

The publication of these findings coincides with an increase in Escherichia coli bloodstream infections in England.

“Our study suggests the early initiation of antibiotics for UTI in older high risk adult populations (especially men aged [older than] 85 years) should be recommended to prevent serious complications,” Dr. Gharbi and her coauthors said in their report.

The population-based cohort study comprised 157,264 adult primary care patients at least 65 years of age who had one or more suspected or confirmed lower UTIs from November 2007 to May 2015. The researchers found that health care providers had diagnosed a total of 312,896 UTI episodes in these patients during the period they studied. In 7.2% (22,534) of the UTI episodes, the researchers were unable to find records of the patients having been prescribed antibiotics by a general practitioner within 7 days of the UTI diagnosis. These 22,534 episodes included those that occurred in patients who had a complication before an antibiotic was prescribed. An additional 6.2% (19,292) of the episodes occurred in patients who were prescribed antibiotics, but not during their first UTI-related visit to a general practitioner or on the same day of such a visit. The researchers classified this group of patients as having been prescribed antibiotics on a deferred or delayed basis, as they were not prescribed such drugs within 7 days of their visit.

Overall, there were 1,539 cases (0.5% of the total number of UTIs) of bloodstream infection within 60 days of the initial urinary tract infection diagnosis, the researchers reported.

The bloodstream infection rate was 2.9% for patients who were not prescribed antibiotics ever or prior to an infection occurring, 2.2% in those who were prescribed antibiotics on a deferred basis, and 0.2% in those who were prescribed antibiotics immediately, meaning during their first visit to a general practitioner for a UTI or on the same day of such a visit (P less than .001). After adjustment for potential confounding variables such as age, sex, and region, the patients classified as having not been prescribed antibiotics or having been prescribed antibiotics on a deferred basis were significantly more likely to have a bloodstream infection within 60 days of their visit to a health care provider, compared with those who received antibiotics immediately, with odds ratios of 8.08 (95% confidence interval, 7.12-9.16) and 7.12 (95% CI, 6.22-8.14), respectively.

Hospital admissions after a UTI episode were nearly twice as high in the no- or deferred-antibiotics groups (27.0% and 26.8%, respectively), compared with the group that received antibiotics right away (14.8%), the investigators reported. The lengths of hospital stays were 12.1 days for the group classified as having not been prescribed antibiotics, 7.7 days for the group subject to delayed antibiotic prescribing, and 6.3 days for the group who received antibiotics immediately.

Deaths within 60 days of experiencing a urinary tract infection occurred in 5.4% of patients in the no-antibiotics group, 2.8% of the deferred-antibiotics group, and 1.6% of the immediate-antibiotics group. After adjustment for covariates, a regression analysis showed the risks for all-cause mortality were 1.16 and 2.18 times higher in the deferred-antibiotics group and the no-antibiotics group, respectively, according to the paper.

In the immediate-antibiotics group, those patients who received nitrofurantoin had a “small but significant increase” in 60-day survival versus those who received trimethoprim, the investigators noted in the discussion section of their report.

“This increase could reflect either higher levels of resistance to trimethoprim or a healthier population treated with nitrofurantoin, the latest being not recommended for patients with poor kidney function,” the researchers wrote.

This study was supported by the National Institute for Health Research and other U.K. sources. One study coauthor reported working as an epidemiologist with GSK in areas not related to the study.

SOURCE: Gharbi M et al. BMJ. 2019 Feb 27. doi: 10.1136/bmj.l525.

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This study linking primary care prescribing to serious infections in elderly patients with urinary tract infections is timely, as rates of bloodstream infection and mortality are increasing in this age group, according to Alastair D. Hay, MB.ChB, a professor at University of Bristol, England.

“Prompt treatment should be offered to older patients, men (who are at higher risk than women), and those living in areas of greater socioeconomic deprivation who are at the highest risk of bloodstream infections,” Dr. Hay said in an editorial accompanying the report by Gharbi et al.

That said, the link between prescribing and infection in this particular study may not be causal: “The implications are likely to be more nuanced than primary care doctors risking the health of older adults to meet targets for antimicrobial stewardship,” Dr. Hay noted.

Doctors are cautious when managing infections in vulnerable groups, evidence shows, and the deferred prescribing reported in this study is likely not the same as the delayed prescribing seen in primary care, he explained.

“Most clinicians issue a prescription on the day of presentation, with verbal advice to delay treatment, rather than waiting for a patient to return or issuing a postdated prescription,” he said. “The group given immediate antibiotics in the study by Gharbi and colleagues likely contained some patients managed in this way.”

Patients who apparently had no prescription in this retrospective analysis may have had a same-day admission with a bloodstream infection; moreover, a number of bloodstream infections in older people are due to urinary tract bacteria, and so would not be prevented by treatment for urinary tract infection, Dr. Hay said.

“Further research is needed to establish whether treatment should be initiated with a broad or a narrow spectrum antibiotic and to identify those in whom delaying treatment (while awaiting investigation) is safe,” he concluded.

Dr. Hay is a professor in the Centre for Academic Primary Care, University of Bristol, England. His editorial appears in The BMJ (2019 Feb 27. doi: 10.1136/bmj.l780). Dr. Hay declared that he is a member of the managing common infections guideline committee for the National Institute for Health and Care Excellence (NICE).

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This study linking primary care prescribing to serious infections in elderly patients with urinary tract infections is timely, as rates of bloodstream infection and mortality are increasing in this age group, according to Alastair D. Hay, MB.ChB, a professor at University of Bristol, England.

“Prompt treatment should be offered to older patients, men (who are at higher risk than women), and those living in areas of greater socioeconomic deprivation who are at the highest risk of bloodstream infections,” Dr. Hay said in an editorial accompanying the report by Gharbi et al.

That said, the link between prescribing and infection in this particular study may not be causal: “The implications are likely to be more nuanced than primary care doctors risking the health of older adults to meet targets for antimicrobial stewardship,” Dr. Hay noted.

Doctors are cautious when managing infections in vulnerable groups, evidence shows, and the deferred prescribing reported in this study is likely not the same as the delayed prescribing seen in primary care, he explained.

“Most clinicians issue a prescription on the day of presentation, with verbal advice to delay treatment, rather than waiting for a patient to return or issuing a postdated prescription,” he said. “The group given immediate antibiotics in the study by Gharbi and colleagues likely contained some patients managed in this way.”

Patients who apparently had no prescription in this retrospective analysis may have had a same-day admission with a bloodstream infection; moreover, a number of bloodstream infections in older people are due to urinary tract bacteria, and so would not be prevented by treatment for urinary tract infection, Dr. Hay said.

“Further research is needed to establish whether treatment should be initiated with a broad or a narrow spectrum antibiotic and to identify those in whom delaying treatment (while awaiting investigation) is safe,” he concluded.

Dr. Hay is a professor in the Centre for Academic Primary Care, University of Bristol, England. His editorial appears in The BMJ (2019 Feb 27. doi: 10.1136/bmj.l780). Dr. Hay declared that he is a member of the managing common infections guideline committee for the National Institute for Health and Care Excellence (NICE).

Body

 

This study linking primary care prescribing to serious infections in elderly patients with urinary tract infections is timely, as rates of bloodstream infection and mortality are increasing in this age group, according to Alastair D. Hay, MB.ChB, a professor at University of Bristol, England.

“Prompt treatment should be offered to older patients, men (who are at higher risk than women), and those living in areas of greater socioeconomic deprivation who are at the highest risk of bloodstream infections,” Dr. Hay said in an editorial accompanying the report by Gharbi et al.

That said, the link between prescribing and infection in this particular study may not be causal: “The implications are likely to be more nuanced than primary care doctors risking the health of older adults to meet targets for antimicrobial stewardship,” Dr. Hay noted.

Doctors are cautious when managing infections in vulnerable groups, evidence shows, and the deferred prescribing reported in this study is likely not the same as the delayed prescribing seen in primary care, he explained.

“Most clinicians issue a prescription on the day of presentation, with verbal advice to delay treatment, rather than waiting for a patient to return or issuing a postdated prescription,” he said. “The group given immediate antibiotics in the study by Gharbi and colleagues likely contained some patients managed in this way.”

Patients who apparently had no prescription in this retrospective analysis may have had a same-day admission with a bloodstream infection; moreover, a number of bloodstream infections in older people are due to urinary tract bacteria, and so would not be prevented by treatment for urinary tract infection, Dr. Hay said.

“Further research is needed to establish whether treatment should be initiated with a broad or a narrow spectrum antibiotic and to identify those in whom delaying treatment (while awaiting investigation) is safe,” he concluded.

Dr. Hay is a professor in the Centre for Academic Primary Care, University of Bristol, England. His editorial appears in The BMJ (2019 Feb 27. doi: 10.1136/bmj.l780). Dr. Hay declared that he is a member of the managing common infections guideline committee for the National Institute for Health and Care Excellence (NICE).

Title
Older patients need prompt treatment
Older patients need prompt treatment

 

Delaying or withholding antibiotics in elderly patients with a urinary tract infection (UTI) increases the risk of sepsis and death, results of a large, population-based study suggest.

andresr/Getty Images

The risk of bloodstream infection was more than seven times greater in patients who did not receive antibiotics immediately after seeing a general practitioner for a UTI versus those who did, according to results of the study based on primary care records and other data for nearly 160,000 U.K. patients aged 65 years or older. Death rates and hospital admissions were significantly higher for these patients, according to the study published in The BMJ by Myriam Gharbi, PharmD, Phd, Imperial College London, and her colleagues.

The publication of these findings coincides with an increase in Escherichia coli bloodstream infections in England.

“Our study suggests the early initiation of antibiotics for UTI in older high risk adult populations (especially men aged [older than] 85 years) should be recommended to prevent serious complications,” Dr. Gharbi and her coauthors said in their report.

The population-based cohort study comprised 157,264 adult primary care patients at least 65 years of age who had one or more suspected or confirmed lower UTIs from November 2007 to May 2015. The researchers found that health care providers had diagnosed a total of 312,896 UTI episodes in these patients during the period they studied. In 7.2% (22,534) of the UTI episodes, the researchers were unable to find records of the patients having been prescribed antibiotics by a general practitioner within 7 days of the UTI diagnosis. These 22,534 episodes included those that occurred in patients who had a complication before an antibiotic was prescribed. An additional 6.2% (19,292) of the episodes occurred in patients who were prescribed antibiotics, but not during their first UTI-related visit to a general practitioner or on the same day of such a visit. The researchers classified this group of patients as having been prescribed antibiotics on a deferred or delayed basis, as they were not prescribed such drugs within 7 days of their visit.

Overall, there were 1,539 cases (0.5% of the total number of UTIs) of bloodstream infection within 60 days of the initial urinary tract infection diagnosis, the researchers reported.

The bloodstream infection rate was 2.9% for patients who were not prescribed antibiotics ever or prior to an infection occurring, 2.2% in those who were prescribed antibiotics on a deferred basis, and 0.2% in those who were prescribed antibiotics immediately, meaning during their first visit to a general practitioner for a UTI or on the same day of such a visit (P less than .001). After adjustment for potential confounding variables such as age, sex, and region, the patients classified as having not been prescribed antibiotics or having been prescribed antibiotics on a deferred basis were significantly more likely to have a bloodstream infection within 60 days of their visit to a health care provider, compared with those who received antibiotics immediately, with odds ratios of 8.08 (95% confidence interval, 7.12-9.16) and 7.12 (95% CI, 6.22-8.14), respectively.

Hospital admissions after a UTI episode were nearly twice as high in the no- or deferred-antibiotics groups (27.0% and 26.8%, respectively), compared with the group that received antibiotics right away (14.8%), the investigators reported. The lengths of hospital stays were 12.1 days for the group classified as having not been prescribed antibiotics, 7.7 days for the group subject to delayed antibiotic prescribing, and 6.3 days for the group who received antibiotics immediately.

Deaths within 60 days of experiencing a urinary tract infection occurred in 5.4% of patients in the no-antibiotics group, 2.8% of the deferred-antibiotics group, and 1.6% of the immediate-antibiotics group. After adjustment for covariates, a regression analysis showed the risks for all-cause mortality were 1.16 and 2.18 times higher in the deferred-antibiotics group and the no-antibiotics group, respectively, according to the paper.

In the immediate-antibiotics group, those patients who received nitrofurantoin had a “small but significant increase” in 60-day survival versus those who received trimethoprim, the investigators noted in the discussion section of their report.

“This increase could reflect either higher levels of resistance to trimethoprim or a healthier population treated with nitrofurantoin, the latest being not recommended for patients with poor kidney function,” the researchers wrote.

This study was supported by the National Institute for Health Research and other U.K. sources. One study coauthor reported working as an epidemiologist with GSK in areas not related to the study.

SOURCE: Gharbi M et al. BMJ. 2019 Feb 27. doi: 10.1136/bmj.l525.

 

Delaying or withholding antibiotics in elderly patients with a urinary tract infection (UTI) increases the risk of sepsis and death, results of a large, population-based study suggest.

andresr/Getty Images

The risk of bloodstream infection was more than seven times greater in patients who did not receive antibiotics immediately after seeing a general practitioner for a UTI versus those who did, according to results of the study based on primary care records and other data for nearly 160,000 U.K. patients aged 65 years or older. Death rates and hospital admissions were significantly higher for these patients, according to the study published in The BMJ by Myriam Gharbi, PharmD, Phd, Imperial College London, and her colleagues.

The publication of these findings coincides with an increase in Escherichia coli bloodstream infections in England.

“Our study suggests the early initiation of antibiotics for UTI in older high risk adult populations (especially men aged [older than] 85 years) should be recommended to prevent serious complications,” Dr. Gharbi and her coauthors said in their report.

The population-based cohort study comprised 157,264 adult primary care patients at least 65 years of age who had one or more suspected or confirmed lower UTIs from November 2007 to May 2015. The researchers found that health care providers had diagnosed a total of 312,896 UTI episodes in these patients during the period they studied. In 7.2% (22,534) of the UTI episodes, the researchers were unable to find records of the patients having been prescribed antibiotics by a general practitioner within 7 days of the UTI diagnosis. These 22,534 episodes included those that occurred in patients who had a complication before an antibiotic was prescribed. An additional 6.2% (19,292) of the episodes occurred in patients who were prescribed antibiotics, but not during their first UTI-related visit to a general practitioner or on the same day of such a visit. The researchers classified this group of patients as having been prescribed antibiotics on a deferred or delayed basis, as they were not prescribed such drugs within 7 days of their visit.

Overall, there were 1,539 cases (0.5% of the total number of UTIs) of bloodstream infection within 60 days of the initial urinary tract infection diagnosis, the researchers reported.

The bloodstream infection rate was 2.9% for patients who were not prescribed antibiotics ever or prior to an infection occurring, 2.2% in those who were prescribed antibiotics on a deferred basis, and 0.2% in those who were prescribed antibiotics immediately, meaning during their first visit to a general practitioner for a UTI or on the same day of such a visit (P less than .001). After adjustment for potential confounding variables such as age, sex, and region, the patients classified as having not been prescribed antibiotics or having been prescribed antibiotics on a deferred basis were significantly more likely to have a bloodstream infection within 60 days of their visit to a health care provider, compared with those who received antibiotics immediately, with odds ratios of 8.08 (95% confidence interval, 7.12-9.16) and 7.12 (95% CI, 6.22-8.14), respectively.

Hospital admissions after a UTI episode were nearly twice as high in the no- or deferred-antibiotics groups (27.0% and 26.8%, respectively), compared with the group that received antibiotics right away (14.8%), the investigators reported. The lengths of hospital stays were 12.1 days for the group classified as having not been prescribed antibiotics, 7.7 days for the group subject to delayed antibiotic prescribing, and 6.3 days for the group who received antibiotics immediately.

Deaths within 60 days of experiencing a urinary tract infection occurred in 5.4% of patients in the no-antibiotics group, 2.8% of the deferred-antibiotics group, and 1.6% of the immediate-antibiotics group. After adjustment for covariates, a regression analysis showed the risks for all-cause mortality were 1.16 and 2.18 times higher in the deferred-antibiotics group and the no-antibiotics group, respectively, according to the paper.

In the immediate-antibiotics group, those patients who received nitrofurantoin had a “small but significant increase” in 60-day survival versus those who received trimethoprim, the investigators noted in the discussion section of their report.

“This increase could reflect either higher levels of resistance to trimethoprim or a healthier population treated with nitrofurantoin, the latest being not recommended for patients with poor kidney function,” the researchers wrote.

This study was supported by the National Institute for Health Research and other U.K. sources. One study coauthor reported working as an epidemiologist with GSK in areas not related to the study.

SOURCE: Gharbi M et al. BMJ. 2019 Feb 27. doi: 10.1136/bmj.l525.

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2019 ID update for dermatologists: Ticks are the “ride of choice” for arthropods

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Tue, 01/29/2019 - 11:01

– New tricks from ticks, near-zero Zika, and the perils of personal grooming: Dermatologists have a lot to think about along the infectious disease spectrum in 2019, according to Justin Finch, MD, speaking at the Orlando Dermatology Aesthetic and Clinical Conference.

Courtesy CDC
Above is the lone star tick that has been linked to anaphylaxis to red meat.

Anaphylaxis from alpha-gal syndrome is on the rise, caused in part by the geographic spread of the Lone Star tick. Beginning in 2006, isolated cases of an anaphylactic reaction to cetuximab, the epidermal growth factor receptor antagonist used to treat certain cancers, began to be seen in a curious geographic distribution. “The anaphylaxis cases were restricted to the southeastern United States, the home of the Lone Star tick,” said Dr. Finch, of the department of dermatology at the University of Connecticut, Farmington.

With some detective work, physicians and epidemiologists eventually determined that patients were reacting to an oligosaccharide called galactose-alpha–1,3-galactose (alpha-gal) found in cetuximab. This protein is also found in the meat of nonprimate mammals; individuals in the southeastern United States, where the Lone Star tick is endemic, had been sensitized via exposure to alpha-gal from Lone Star tick bites.


“Alpha-gal syndrome is on the rise,” said Dr. Finch, driven by the increased spread of this tick. Individuals who are sensitized develop delayed anaphylaxis 2-7 hours after ingesting red meat such as beef, pork, or lamb. “Ask about it,” said Dr. Finch, in patients who develop urticaria, dyspnea, angioedema, or hypotension without a clear offender. Because of the delay between allergen ingestion and anaphylaxis, it can be hard to connect the dots.

A number of drugs other than cetuximab contain alpha-gal, so patients must also be told to avoid these agents, said Dr. Finch, who noted that alpha-gal syndrome isn’t the only emerging culprit for tick-borne diseases. “The tick is the ride of choice for arthropod-borne diseases in the U.S.,” he added. “Year after year, tick-borne diseases top mosquito-borne diseases in the U.S.” Zika’s explosion in 2016 made that year the exception to the rule.

Dr. Stephen K. Tyring, Dr. Zeena Nawas, The University of
Blanchable macules and papules start on the face or trunk, 3-5 days after the febrile phase of Zika virus, and become more diffuse.

Now, Zika virus may be on the wane – the number of case reports have plummeted both in the United States and in Central and South America this past year – but it hasn’t completely gone away. “It looks like it fell off all the maps,” but the virus is still present at low levels, he said.

When Zika virus is symptomatic, there’s often a nonspecific maculopapular rash. Critically, Dr. Finch said, “women with a rash are four times as likely to have adverse congenital outcomes. This is the important point for us to take home as dermatologists. ... It’s really important to have a high index of suspicion and to screen these women as they are coming into our clinic.”

Turning back to ticks, Lyme disease continues to be a problem in endemic areas in the Northeast, the mid-Atlantic region, and the Midwest, said Dr. Finch, so it’s a perennial on the differential diagnosis for dermatologists.

An Asian tick new to North America was seen for the first time in New Jersey in the summer of 2017. The Asian longhorned tick carries a phlebovirus that causes severe fever with thrombocytopenia syndrome, a disease with a 15% fatality rate. The reservoir host of this virus in Asia isn’t known, said Dr. Finch, adding that no cases of the virus have yet been seen in the United States. As of November 2018, according to the Centers for Disease Control and Prevention, the tick had been found in nine states (Arkansas, Connecticut, Maryland, North Carolina, New Jersey, New York, Pennsylvania, Virginia, and West Virginia).

“What’s not on the rise? Pubic lice. We are destroying their natural habitat!” said Dr. Finch, citing surveys about personal grooming that show that more than 90% of women remove at least some of their pubic hair. Most college campuses are currently reporting essentially no cases of pubic lice, he noted.

However, the same personal grooming practices may be contributing to increases in molluscum contagiosum, herpes simplex virus, some strains of human papillomavirus, and cutaneous Streptococcus pyogenes infections, he said.

Another STI has had a resurgence in geographic pockets around the nation and among specific populations, said Dr. Finch. Syphilis is on the rise among gay and bisexual men and African Americans. Known as the “great imitator,” syphilis should be on the differential for dermatologists when the clinical picture isn’t quite adding up. “Think of this, and screen with an RPR [rapid plasma reagin],” he said.

Finally, an old enemy is back: A total of 11 measles outbreaks were reported in 2018. “We need to know about measles because of the complications,” said Dr. Finch. Even years later, such dire sequelae as subacute sclerosing panencephalitis can crop up, he added.

CDC/Dr. Heinz F. Eichenwald
This is the skin of a patient after 3 days of measles infection.

After a 2-week incubation period, measles begins with a fever and cough, congestion, and conjunctivitis. The rash begins on the head and spreads inferiorly by day 3. As the rash blooms, the classic morbilliform eruption becomes apparent. A biopsy of affected skin will be nonspecific; measles is diagnosed with a nasopharyngeal culture and serologic assay. Dr. Finch pointed out that dermatologists are unlikely to see measles in its earliest stages because their expertise will be called on only after it becomes clear that the patient is not experiencing just a mild illness with a viral exanthem.

When there’s suspicion for measles, a full-body skin exam is needed. “Koplik’s spots – the gray white papules on the buccal mucosa – are not pathognomonic in themselves, but in the clinical scenario of a person with measles” they can help the dermatologist make a definitive call, he said.

Vitamin A can be given to a patient with active measles, but prevention via immunization at age 12 months and 5 years is the only way to stop the disease, Dr. Finch noted.

Dr. Finch reported that he has no relevant conflicts of interest.

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– New tricks from ticks, near-zero Zika, and the perils of personal grooming: Dermatologists have a lot to think about along the infectious disease spectrum in 2019, according to Justin Finch, MD, speaking at the Orlando Dermatology Aesthetic and Clinical Conference.

Courtesy CDC
Above is the lone star tick that has been linked to anaphylaxis to red meat.

Anaphylaxis from alpha-gal syndrome is on the rise, caused in part by the geographic spread of the Lone Star tick. Beginning in 2006, isolated cases of an anaphylactic reaction to cetuximab, the epidermal growth factor receptor antagonist used to treat certain cancers, began to be seen in a curious geographic distribution. “The anaphylaxis cases were restricted to the southeastern United States, the home of the Lone Star tick,” said Dr. Finch, of the department of dermatology at the University of Connecticut, Farmington.

With some detective work, physicians and epidemiologists eventually determined that patients were reacting to an oligosaccharide called galactose-alpha–1,3-galactose (alpha-gal) found in cetuximab. This protein is also found in the meat of nonprimate mammals; individuals in the southeastern United States, where the Lone Star tick is endemic, had been sensitized via exposure to alpha-gal from Lone Star tick bites.


“Alpha-gal syndrome is on the rise,” said Dr. Finch, driven by the increased spread of this tick. Individuals who are sensitized develop delayed anaphylaxis 2-7 hours after ingesting red meat such as beef, pork, or lamb. “Ask about it,” said Dr. Finch, in patients who develop urticaria, dyspnea, angioedema, or hypotension without a clear offender. Because of the delay between allergen ingestion and anaphylaxis, it can be hard to connect the dots.

A number of drugs other than cetuximab contain alpha-gal, so patients must also be told to avoid these agents, said Dr. Finch, who noted that alpha-gal syndrome isn’t the only emerging culprit for tick-borne diseases. “The tick is the ride of choice for arthropod-borne diseases in the U.S.,” he added. “Year after year, tick-borne diseases top mosquito-borne diseases in the U.S.” Zika’s explosion in 2016 made that year the exception to the rule.

Dr. Stephen K. Tyring, Dr. Zeena Nawas, The University of
Blanchable macules and papules start on the face or trunk, 3-5 days after the febrile phase of Zika virus, and become more diffuse.

Now, Zika virus may be on the wane – the number of case reports have plummeted both in the United States and in Central and South America this past year – but it hasn’t completely gone away. “It looks like it fell off all the maps,” but the virus is still present at low levels, he said.

When Zika virus is symptomatic, there’s often a nonspecific maculopapular rash. Critically, Dr. Finch said, “women with a rash are four times as likely to have adverse congenital outcomes. This is the important point for us to take home as dermatologists. ... It’s really important to have a high index of suspicion and to screen these women as they are coming into our clinic.”

Turning back to ticks, Lyme disease continues to be a problem in endemic areas in the Northeast, the mid-Atlantic region, and the Midwest, said Dr. Finch, so it’s a perennial on the differential diagnosis for dermatologists.

An Asian tick new to North America was seen for the first time in New Jersey in the summer of 2017. The Asian longhorned tick carries a phlebovirus that causes severe fever with thrombocytopenia syndrome, a disease with a 15% fatality rate. The reservoir host of this virus in Asia isn’t known, said Dr. Finch, adding that no cases of the virus have yet been seen in the United States. As of November 2018, according to the Centers for Disease Control and Prevention, the tick had been found in nine states (Arkansas, Connecticut, Maryland, North Carolina, New Jersey, New York, Pennsylvania, Virginia, and West Virginia).

“What’s not on the rise? Pubic lice. We are destroying their natural habitat!” said Dr. Finch, citing surveys about personal grooming that show that more than 90% of women remove at least some of their pubic hair. Most college campuses are currently reporting essentially no cases of pubic lice, he noted.

However, the same personal grooming practices may be contributing to increases in molluscum contagiosum, herpes simplex virus, some strains of human papillomavirus, and cutaneous Streptococcus pyogenes infections, he said.

Another STI has had a resurgence in geographic pockets around the nation and among specific populations, said Dr. Finch. Syphilis is on the rise among gay and bisexual men and African Americans. Known as the “great imitator,” syphilis should be on the differential for dermatologists when the clinical picture isn’t quite adding up. “Think of this, and screen with an RPR [rapid plasma reagin],” he said.

Finally, an old enemy is back: A total of 11 measles outbreaks were reported in 2018. “We need to know about measles because of the complications,” said Dr. Finch. Even years later, such dire sequelae as subacute sclerosing panencephalitis can crop up, he added.

CDC/Dr. Heinz F. Eichenwald
This is the skin of a patient after 3 days of measles infection.

After a 2-week incubation period, measles begins with a fever and cough, congestion, and conjunctivitis. The rash begins on the head and spreads inferiorly by day 3. As the rash blooms, the classic morbilliform eruption becomes apparent. A biopsy of affected skin will be nonspecific; measles is diagnosed with a nasopharyngeal culture and serologic assay. Dr. Finch pointed out that dermatologists are unlikely to see measles in its earliest stages because their expertise will be called on only after it becomes clear that the patient is not experiencing just a mild illness with a viral exanthem.

When there’s suspicion for measles, a full-body skin exam is needed. “Koplik’s spots – the gray white papules on the buccal mucosa – are not pathognomonic in themselves, but in the clinical scenario of a person with measles” they can help the dermatologist make a definitive call, he said.

Vitamin A can be given to a patient with active measles, but prevention via immunization at age 12 months and 5 years is the only way to stop the disease, Dr. Finch noted.

Dr. Finch reported that he has no relevant conflicts of interest.

– New tricks from ticks, near-zero Zika, and the perils of personal grooming: Dermatologists have a lot to think about along the infectious disease spectrum in 2019, according to Justin Finch, MD, speaking at the Orlando Dermatology Aesthetic and Clinical Conference.

Courtesy CDC
Above is the lone star tick that has been linked to anaphylaxis to red meat.

Anaphylaxis from alpha-gal syndrome is on the rise, caused in part by the geographic spread of the Lone Star tick. Beginning in 2006, isolated cases of an anaphylactic reaction to cetuximab, the epidermal growth factor receptor antagonist used to treat certain cancers, began to be seen in a curious geographic distribution. “The anaphylaxis cases were restricted to the southeastern United States, the home of the Lone Star tick,” said Dr. Finch, of the department of dermatology at the University of Connecticut, Farmington.

With some detective work, physicians and epidemiologists eventually determined that patients were reacting to an oligosaccharide called galactose-alpha–1,3-galactose (alpha-gal) found in cetuximab. This protein is also found in the meat of nonprimate mammals; individuals in the southeastern United States, where the Lone Star tick is endemic, had been sensitized via exposure to alpha-gal from Lone Star tick bites.


“Alpha-gal syndrome is on the rise,” said Dr. Finch, driven by the increased spread of this tick. Individuals who are sensitized develop delayed anaphylaxis 2-7 hours after ingesting red meat such as beef, pork, or lamb. “Ask about it,” said Dr. Finch, in patients who develop urticaria, dyspnea, angioedema, or hypotension without a clear offender. Because of the delay between allergen ingestion and anaphylaxis, it can be hard to connect the dots.

A number of drugs other than cetuximab contain alpha-gal, so patients must also be told to avoid these agents, said Dr. Finch, who noted that alpha-gal syndrome isn’t the only emerging culprit for tick-borne diseases. “The tick is the ride of choice for arthropod-borne diseases in the U.S.,” he added. “Year after year, tick-borne diseases top mosquito-borne diseases in the U.S.” Zika’s explosion in 2016 made that year the exception to the rule.

Dr. Stephen K. Tyring, Dr. Zeena Nawas, The University of
Blanchable macules and papules start on the face or trunk, 3-5 days after the febrile phase of Zika virus, and become more diffuse.

Now, Zika virus may be on the wane – the number of case reports have plummeted both in the United States and in Central and South America this past year – but it hasn’t completely gone away. “It looks like it fell off all the maps,” but the virus is still present at low levels, he said.

When Zika virus is symptomatic, there’s often a nonspecific maculopapular rash. Critically, Dr. Finch said, “women with a rash are four times as likely to have adverse congenital outcomes. This is the important point for us to take home as dermatologists. ... It’s really important to have a high index of suspicion and to screen these women as they are coming into our clinic.”

Turning back to ticks, Lyme disease continues to be a problem in endemic areas in the Northeast, the mid-Atlantic region, and the Midwest, said Dr. Finch, so it’s a perennial on the differential diagnosis for dermatologists.

An Asian tick new to North America was seen for the first time in New Jersey in the summer of 2017. The Asian longhorned tick carries a phlebovirus that causes severe fever with thrombocytopenia syndrome, a disease with a 15% fatality rate. The reservoir host of this virus in Asia isn’t known, said Dr. Finch, adding that no cases of the virus have yet been seen in the United States. As of November 2018, according to the Centers for Disease Control and Prevention, the tick had been found in nine states (Arkansas, Connecticut, Maryland, North Carolina, New Jersey, New York, Pennsylvania, Virginia, and West Virginia).

“What’s not on the rise? Pubic lice. We are destroying their natural habitat!” said Dr. Finch, citing surveys about personal grooming that show that more than 90% of women remove at least some of their pubic hair. Most college campuses are currently reporting essentially no cases of pubic lice, he noted.

However, the same personal grooming practices may be contributing to increases in molluscum contagiosum, herpes simplex virus, some strains of human papillomavirus, and cutaneous Streptococcus pyogenes infections, he said.

Another STI has had a resurgence in geographic pockets around the nation and among specific populations, said Dr. Finch. Syphilis is on the rise among gay and bisexual men and African Americans. Known as the “great imitator,” syphilis should be on the differential for dermatologists when the clinical picture isn’t quite adding up. “Think of this, and screen with an RPR [rapid plasma reagin],” he said.

Finally, an old enemy is back: A total of 11 measles outbreaks were reported in 2018. “We need to know about measles because of the complications,” said Dr. Finch. Even years later, such dire sequelae as subacute sclerosing panencephalitis can crop up, he added.

CDC/Dr. Heinz F. Eichenwald
This is the skin of a patient after 3 days of measles infection.

After a 2-week incubation period, measles begins with a fever and cough, congestion, and conjunctivitis. The rash begins on the head and spreads inferiorly by day 3. As the rash blooms, the classic morbilliform eruption becomes apparent. A biopsy of affected skin will be nonspecific; measles is diagnosed with a nasopharyngeal culture and serologic assay. Dr. Finch pointed out that dermatologists are unlikely to see measles in its earliest stages because their expertise will be called on only after it becomes clear that the patient is not experiencing just a mild illness with a viral exanthem.

When there’s suspicion for measles, a full-body skin exam is needed. “Koplik’s spots – the gray white papules on the buccal mucosa – are not pathognomonic in themselves, but in the clinical scenario of a person with measles” they can help the dermatologist make a definitive call, he said.

Vitamin A can be given to a patient with active measles, but prevention via immunization at age 12 months and 5 years is the only way to stop the disease, Dr. Finch noted.

Dr. Finch reported that he has no relevant conflicts of interest.

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Deadly Marburg virus found in West Africa

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Thu, 01/10/2019 - 08:48

Marburg virus has been found in fruit bats in Sierra Leone, marking the first appearance of the deadly, Ebola-like virus in West Africa, the Centers for Disease Control and Prevention (CDC) is reporting.

Wikimedia Commons/Mickey Samuni-Blank
Baby Egyptian fruit bat (Rousettus aegyptiacus), known carrier species of deadly Marburg virus.

Five Egyptian rousette fruit bats found in three different districts tested positive for infection with Marburg virus, a cousin to Ebola that can cause a hemorrhagic fever with case fatality rates up to 90%, according to CDC.

While no confirmed cases of Marburg infection have been reported in Sierra Leone, the presence of virus in these bats indicates that people nearby may be at risk, according to scientists.

“We have known for a long time that rousette bats, which carry Marburg virus in other parts of Africa, also live in West Africa, so it’s not surprising that we’d find the virus in bats there,” CDC ecologist Jonathan S. Towner, PhD, said in a news release.

The Egyptian rousette bat (Rousettus aegyptiacus) is the natural reservoir for Marburg, shedding the virus in saliva, urine, and feces while feeding on fruit. People and are exposed to the virus when they eat contaminated fruit or capture bats for food, according to the CDC.

The most recent Marburg virus outbreak, which occurred in Uganda in 2017, was the 12th reported outbreak linked to Africa, according to the agency. The largest and deadliest outbreak occurred in 2005 in Angola, infecting 252 people, of whom 90% died.

Testing of the Marburg-positive bats revealed genetically diverse strains, suggesting the virus has been present in Sierra Leone bat colonies for many years, the agency said. Two of the four Marburg virus strains identified in the Sierra Leone bats were genetically similar to the strain implicated in the Angola outbreak.

Egyptian fruit bats are in fact common throughout Africa, living in caves or underground mines. Marburg-positive bats have been found in sub-Saharan Africa, according to researchers, mainly in Uganda and the Democratic Republic of Congo.

Colonies of Egyptian fruit bats can number more than 100,000 animals in eastern and central Africa, while in Sierra Leone, colonies are much smaller, which may explain the lack of Marburg virus disease outbreaks in that country, CDC said.

Discovery of Marburg virus in Sierra Leone was the result of two projects, one led by the CDC and Njala University in Freetown, Sierra Leone, and the other by the University of California, Davis, and the University of Makeni, Sierra Leone, which was funded by the United States Agency for International Development (USAID).

“This discovery is an excellent example of how our work can identify a threat and help us warn people of the risk before they get sick.” Dr. Towner said in the news release.

The two projects began in 2016 after the large Ebola outbreak in West Africa with the aim of identifying the reservoir of Ebola, according to CDC.

SOURCES: U.S. Department of Health and Human Services CDC Newsroom and Centers for Disease Control and Prevention (Marburg Virus).

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Marburg virus has been found in fruit bats in Sierra Leone, marking the first appearance of the deadly, Ebola-like virus in West Africa, the Centers for Disease Control and Prevention (CDC) is reporting.

Wikimedia Commons/Mickey Samuni-Blank
Baby Egyptian fruit bat (Rousettus aegyptiacus), known carrier species of deadly Marburg virus.

Five Egyptian rousette fruit bats found in three different districts tested positive for infection with Marburg virus, a cousin to Ebola that can cause a hemorrhagic fever with case fatality rates up to 90%, according to CDC.

While no confirmed cases of Marburg infection have been reported in Sierra Leone, the presence of virus in these bats indicates that people nearby may be at risk, according to scientists.

“We have known for a long time that rousette bats, which carry Marburg virus in other parts of Africa, also live in West Africa, so it’s not surprising that we’d find the virus in bats there,” CDC ecologist Jonathan S. Towner, PhD, said in a news release.

The Egyptian rousette bat (Rousettus aegyptiacus) is the natural reservoir for Marburg, shedding the virus in saliva, urine, and feces while feeding on fruit. People and are exposed to the virus when they eat contaminated fruit or capture bats for food, according to the CDC.

The most recent Marburg virus outbreak, which occurred in Uganda in 2017, was the 12th reported outbreak linked to Africa, according to the agency. The largest and deadliest outbreak occurred in 2005 in Angola, infecting 252 people, of whom 90% died.

Testing of the Marburg-positive bats revealed genetically diverse strains, suggesting the virus has been present in Sierra Leone bat colonies for many years, the agency said. Two of the four Marburg virus strains identified in the Sierra Leone bats were genetically similar to the strain implicated in the Angola outbreak.

Egyptian fruit bats are in fact common throughout Africa, living in caves or underground mines. Marburg-positive bats have been found in sub-Saharan Africa, according to researchers, mainly in Uganda and the Democratic Republic of Congo.

Colonies of Egyptian fruit bats can number more than 100,000 animals in eastern and central Africa, while in Sierra Leone, colonies are much smaller, which may explain the lack of Marburg virus disease outbreaks in that country, CDC said.

Discovery of Marburg virus in Sierra Leone was the result of two projects, one led by the CDC and Njala University in Freetown, Sierra Leone, and the other by the University of California, Davis, and the University of Makeni, Sierra Leone, which was funded by the United States Agency for International Development (USAID).

“This discovery is an excellent example of how our work can identify a threat and help us warn people of the risk before they get sick.” Dr. Towner said in the news release.

The two projects began in 2016 after the large Ebola outbreak in West Africa with the aim of identifying the reservoir of Ebola, according to CDC.

SOURCES: U.S. Department of Health and Human Services CDC Newsroom and Centers for Disease Control and Prevention (Marburg Virus).

Marburg virus has been found in fruit bats in Sierra Leone, marking the first appearance of the deadly, Ebola-like virus in West Africa, the Centers for Disease Control and Prevention (CDC) is reporting.

Wikimedia Commons/Mickey Samuni-Blank
Baby Egyptian fruit bat (Rousettus aegyptiacus), known carrier species of deadly Marburg virus.

Five Egyptian rousette fruit bats found in three different districts tested positive for infection with Marburg virus, a cousin to Ebola that can cause a hemorrhagic fever with case fatality rates up to 90%, according to CDC.

While no confirmed cases of Marburg infection have been reported in Sierra Leone, the presence of virus in these bats indicates that people nearby may be at risk, according to scientists.

“We have known for a long time that rousette bats, which carry Marburg virus in other parts of Africa, also live in West Africa, so it’s not surprising that we’d find the virus in bats there,” CDC ecologist Jonathan S. Towner, PhD, said in a news release.

The Egyptian rousette bat (Rousettus aegyptiacus) is the natural reservoir for Marburg, shedding the virus in saliva, urine, and feces while feeding on fruit. People and are exposed to the virus when they eat contaminated fruit or capture bats for food, according to the CDC.

The most recent Marburg virus outbreak, which occurred in Uganda in 2017, was the 12th reported outbreak linked to Africa, according to the agency. The largest and deadliest outbreak occurred in 2005 in Angola, infecting 252 people, of whom 90% died.

Testing of the Marburg-positive bats revealed genetically diverse strains, suggesting the virus has been present in Sierra Leone bat colonies for many years, the agency said. Two of the four Marburg virus strains identified in the Sierra Leone bats were genetically similar to the strain implicated in the Angola outbreak.

Egyptian fruit bats are in fact common throughout Africa, living in caves or underground mines. Marburg-positive bats have been found in sub-Saharan Africa, according to researchers, mainly in Uganda and the Democratic Republic of Congo.

Colonies of Egyptian fruit bats can number more than 100,000 animals in eastern and central Africa, while in Sierra Leone, colonies are much smaller, which may explain the lack of Marburg virus disease outbreaks in that country, CDC said.

Discovery of Marburg virus in Sierra Leone was the result of two projects, one led by the CDC and Njala University in Freetown, Sierra Leone, and the other by the University of California, Davis, and the University of Makeni, Sierra Leone, which was funded by the United States Agency for International Development (USAID).

“This discovery is an excellent example of how our work can identify a threat and help us warn people of the risk before they get sick.” Dr. Towner said in the news release.

The two projects began in 2016 after the large Ebola outbreak in West Africa with the aim of identifying the reservoir of Ebola, according to CDC.

SOURCES: U.S. Department of Health and Human Services CDC Newsroom and Centers for Disease Control and Prevention (Marburg Virus).

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Mysterious polio-like illness baffles medical experts while frightening parents

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Fri, 01/18/2019 - 18:02

 

A spike in the number of children with a rare neurological disease that causes polio-like symptoms has health officials across the country scrambling to understand the illness. Yet, more than 4 years after health officials first recorded the most recent uptick in cases, much about the national outbreak remains a mystery.

Courtesy Centers for Disease Control and Prevention

Acute flaccid myelitis (AFM) affects the gray matter in the spinal cord, causing sudden muscle weakness and a loss of reflexes. The illness can lead to serious complications – including paralysis or respiratory failure – and requires immediate medical attention.

The Centers for Disease Control and Prevention is investigating 127 cases of possible AFM, including 62 that have been confirmed in 22 states this year. At least 90% of the cases are among patients 18 years old and younger. The average age of a patient is 4 years old.

AFM remains extremely rare, even with the recent increase. The CDC estimates fewer than 1 in a million Americans will get the disease. Officials advised parents not to panic but remain vigilant for any sudden onset of symptoms. They also suggested that children stay up to date with their vaccines and practice good hand washing habits.

This year’s outbreak marks the third spike of AFM in 4 years. From August 2014 to September 2018, 386 cases have been confirmed. Yet, experts still do not understand crucial aspects of the disease, including its origins and who is most at risk.

“There is a lot we don’t know about AFM,” said Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases. Here’s what puzzles health officials about AFM:
 

The cause is still unknown

Acute flaccid myelitis can be caused by viruses, such as polio or West Nile. But federal officials said that those viruses have not been linked to the U.S. outbreak over the past 4 years. They have not isolated the cause of these cases.

Despite symptoms reminiscent of polio, no AFM cases have tested positive for that virus, according to the CDC. Investigators have also ruled out a variety of germs. Environmental agents, viruses, and other pathogens are still being considered.

The 2014 outbreak of AFM coincided with a surge of another virus that caused severe respiratory problems, called EV-D68. However, the CDC could not establish a causal link between AFM and the virus. Since then, no large outbreaks of the virus have occurred, according to the CDC.

Carlos Pardo-Villamizar, MD, a neurologist and director of the Johns Hopkins Transverse Myelitis Center, said that the mystery lies in whether the damage seen in AFM is caused by an external agent or the body’s own defenses.

“At this moment, we don’t know if it’s a virus that is coming and producing direct damage of the gray matter in the spinal cord,” he said, “or if a virus is triggering immunological responses that produce a secondary damage in the spinal cord.”

 

 

It’s not clear who is at risk

Although the disease appears to target a certain age group, federal disease experts do not know who is likely to get acute flaccid myelitis.

Dr. Pardo-Villamizar said identifying vulnerable populations is “a work in progress.”

Mary Anne Jackson, MD, a pediatric infectious disease specialist and interim dean of the school of medicine at the University of Missouri–Kansas City, said many of the patients she saw were healthy children before falling ill with the disease. She suspects that a host of factors play a role in the likelihood of getting AFM, but more cases must be reviewed in order to find an answer.
 

The long-term effects are unknown

The CDC said it doesn’t know how long symptoms of the disease will last for patients. However, experts say that initial indications from a small number of cases suggest a grim outlook.

A study published last year found six of eight children in Colorado with acute flaccid myelitis still struggled with motor skills 1 year after their diagnosis. Nonetheless, the researchers found that the patients and families “demonstrated a high degree of resilience and recovery.”

“The majority of these patients are left with extensive problems,” said Dr. Pardo-Villamizar, who was not involved in the study.

Dr. Jackson, who also saw persistent muscle weakness in her patients, said she believes the CDC may be hesitant to specify the long-term effects of the disease because existing studies have included only small numbers of patients. More studies that include a larger proportion of confirmed cases are needed to better understand long-term outcomes, she said.
 

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

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A spike in the number of children with a rare neurological disease that causes polio-like symptoms has health officials across the country scrambling to understand the illness. Yet, more than 4 years after health officials first recorded the most recent uptick in cases, much about the national outbreak remains a mystery.

Courtesy Centers for Disease Control and Prevention

Acute flaccid myelitis (AFM) affects the gray matter in the spinal cord, causing sudden muscle weakness and a loss of reflexes. The illness can lead to serious complications – including paralysis or respiratory failure – and requires immediate medical attention.

The Centers for Disease Control and Prevention is investigating 127 cases of possible AFM, including 62 that have been confirmed in 22 states this year. At least 90% of the cases are among patients 18 years old and younger. The average age of a patient is 4 years old.

AFM remains extremely rare, even with the recent increase. The CDC estimates fewer than 1 in a million Americans will get the disease. Officials advised parents not to panic but remain vigilant for any sudden onset of symptoms. They also suggested that children stay up to date with their vaccines and practice good hand washing habits.

This year’s outbreak marks the third spike of AFM in 4 years. From August 2014 to September 2018, 386 cases have been confirmed. Yet, experts still do not understand crucial aspects of the disease, including its origins and who is most at risk.

“There is a lot we don’t know about AFM,” said Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases. Here’s what puzzles health officials about AFM:
 

The cause is still unknown

Acute flaccid myelitis can be caused by viruses, such as polio or West Nile. But federal officials said that those viruses have not been linked to the U.S. outbreak over the past 4 years. They have not isolated the cause of these cases.

Despite symptoms reminiscent of polio, no AFM cases have tested positive for that virus, according to the CDC. Investigators have also ruled out a variety of germs. Environmental agents, viruses, and other pathogens are still being considered.

The 2014 outbreak of AFM coincided with a surge of another virus that caused severe respiratory problems, called EV-D68. However, the CDC could not establish a causal link between AFM and the virus. Since then, no large outbreaks of the virus have occurred, according to the CDC.

Carlos Pardo-Villamizar, MD, a neurologist and director of the Johns Hopkins Transverse Myelitis Center, said that the mystery lies in whether the damage seen in AFM is caused by an external agent or the body’s own defenses.

“At this moment, we don’t know if it’s a virus that is coming and producing direct damage of the gray matter in the spinal cord,” he said, “or if a virus is triggering immunological responses that produce a secondary damage in the spinal cord.”

 

 

It’s not clear who is at risk

Although the disease appears to target a certain age group, federal disease experts do not know who is likely to get acute flaccid myelitis.

Dr. Pardo-Villamizar said identifying vulnerable populations is “a work in progress.”

Mary Anne Jackson, MD, a pediatric infectious disease specialist and interim dean of the school of medicine at the University of Missouri–Kansas City, said many of the patients she saw were healthy children before falling ill with the disease. She suspects that a host of factors play a role in the likelihood of getting AFM, but more cases must be reviewed in order to find an answer.
 

The long-term effects are unknown

The CDC said it doesn’t know how long symptoms of the disease will last for patients. However, experts say that initial indications from a small number of cases suggest a grim outlook.

A study published last year found six of eight children in Colorado with acute flaccid myelitis still struggled with motor skills 1 year after their diagnosis. Nonetheless, the researchers found that the patients and families “demonstrated a high degree of resilience and recovery.”

“The majority of these patients are left with extensive problems,” said Dr. Pardo-Villamizar, who was not involved in the study.

Dr. Jackson, who also saw persistent muscle weakness in her patients, said she believes the CDC may be hesitant to specify the long-term effects of the disease because existing studies have included only small numbers of patients. More studies that include a larger proportion of confirmed cases are needed to better understand long-term outcomes, she said.
 

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

 

A spike in the number of children with a rare neurological disease that causes polio-like symptoms has health officials across the country scrambling to understand the illness. Yet, more than 4 years after health officials first recorded the most recent uptick in cases, much about the national outbreak remains a mystery.

Courtesy Centers for Disease Control and Prevention

Acute flaccid myelitis (AFM) affects the gray matter in the spinal cord, causing sudden muscle weakness and a loss of reflexes. The illness can lead to serious complications – including paralysis or respiratory failure – and requires immediate medical attention.

The Centers for Disease Control and Prevention is investigating 127 cases of possible AFM, including 62 that have been confirmed in 22 states this year. At least 90% of the cases are among patients 18 years old and younger. The average age of a patient is 4 years old.

AFM remains extremely rare, even with the recent increase. The CDC estimates fewer than 1 in a million Americans will get the disease. Officials advised parents not to panic but remain vigilant for any sudden onset of symptoms. They also suggested that children stay up to date with their vaccines and practice good hand washing habits.

This year’s outbreak marks the third spike of AFM in 4 years. From August 2014 to September 2018, 386 cases have been confirmed. Yet, experts still do not understand crucial aspects of the disease, including its origins and who is most at risk.

“There is a lot we don’t know about AFM,” said Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases. Here’s what puzzles health officials about AFM:
 

The cause is still unknown

Acute flaccid myelitis can be caused by viruses, such as polio or West Nile. But federal officials said that those viruses have not been linked to the U.S. outbreak over the past 4 years. They have not isolated the cause of these cases.

Despite symptoms reminiscent of polio, no AFM cases have tested positive for that virus, according to the CDC. Investigators have also ruled out a variety of germs. Environmental agents, viruses, and other pathogens are still being considered.

The 2014 outbreak of AFM coincided with a surge of another virus that caused severe respiratory problems, called EV-D68. However, the CDC could not establish a causal link between AFM and the virus. Since then, no large outbreaks of the virus have occurred, according to the CDC.

Carlos Pardo-Villamizar, MD, a neurologist and director of the Johns Hopkins Transverse Myelitis Center, said that the mystery lies in whether the damage seen in AFM is caused by an external agent or the body’s own defenses.

“At this moment, we don’t know if it’s a virus that is coming and producing direct damage of the gray matter in the spinal cord,” he said, “or if a virus is triggering immunological responses that produce a secondary damage in the spinal cord.”

 

 

It’s not clear who is at risk

Although the disease appears to target a certain age group, federal disease experts do not know who is likely to get acute flaccid myelitis.

Dr. Pardo-Villamizar said identifying vulnerable populations is “a work in progress.”

Mary Anne Jackson, MD, a pediatric infectious disease specialist and interim dean of the school of medicine at the University of Missouri–Kansas City, said many of the patients she saw were healthy children before falling ill with the disease. She suspects that a host of factors play a role in the likelihood of getting AFM, but more cases must be reviewed in order to find an answer.
 

The long-term effects are unknown

The CDC said it doesn’t know how long symptoms of the disease will last for patients. However, experts say that initial indications from a small number of cases suggest a grim outlook.

A study published last year found six of eight children in Colorado with acute flaccid myelitis still struggled with motor skills 1 year after their diagnosis. Nonetheless, the researchers found that the patients and families “demonstrated a high degree of resilience and recovery.”

“The majority of these patients are left with extensive problems,” said Dr. Pardo-Villamizar, who was not involved in the study.

Dr. Jackson, who also saw persistent muscle weakness in her patients, said she believes the CDC may be hesitant to specify the long-term effects of the disease because existing studies have included only small numbers of patients. More studies that include a larger proportion of confirmed cases are needed to better understand long-term outcomes, she said.
 

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

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Novel recombinant vaccine protects animals from Lassa fever

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Sat, 12/08/2018 - 15:24

 

An inactivated recombinant Lassa virus (LASV) and rabies vaccine candidate was developed that protects both mice and guinea pigs from Lassa fever. The vaccine also elicits a lasting humoral response against both LASV and rabies virus in both animal models. The novel vaccine, which uses a rabies virus–derived vector, expresses a codon-optimized LASV glycoprotein, according to Tiago Abreu Mota, a doctoral student at Jefferson University, Philadelphia, and his colleagues.

CDC/C.S. Goldsmith

Lassa fever, a World Health Organization priority disease with a biosafety level of 4, is a hemorrhagic fever caused by the Lassa virus, which has no approved vaccine or potent antiviral treatment, according to the report published online in Nature Communications. So the development of a vaccine would be an important step in protecting the West African population from this deadly disease, which infects an estimated 100,000-300,000 people annually. As many as 80% of Lassa fever exposures are mildly symptomatic and thus go unreported; however, the case fatality rate of full-blown Lassa fever has been reported to reach as high as 50%, according to Mr. Mota and his colleagues.

An advantage to the new vaccine is that it is inactivated and thus could potentially be used in pregnant women and immunosuppressed patients, both of which are major risk groups for Lassa fever, according to the researchers. The vaccine could also protect against rabies, which is another major health concern in the regions affected by the Lassa virus.

In terms of mechanism of action, the vaccine did not induce virus-neutralizing antibodies, but rather appeared to trigger cell-mediated protection through activating natural killer cells to promote significantly more killing of virus-infected cells than nontriggered NK cells (P less than .01), as seen through in vitro testing.

The ability to assay for this form of vaccine effectiveness was a key development, according to the researchers. “The neutralizing antibody has been something of a gold standard in vaccine development. High levels are usually a good indication that the immune reaction is strong enough to deflect viral disease. In the case of Lassa virus, however, neutralizing antibodies have not been very good surrogates, since they are produced in much lower quantities. ... The new surrogate of protection will aid in the development of a more potent vaccine against Lassa virus,” according to a press release by Jefferson University.

This work was supported by various grants from the National Institutes of Health. Mr. Mota and two of his colleagues are inventors on a U.S. provisional patent application for a recombinant Lassa-rabies vaccine.

SOURCE: Mota TA et al. Nat Commun. 2018;9:4223. doi: 10.1038/s41467-018-06741-w.

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An inactivated recombinant Lassa virus (LASV) and rabies vaccine candidate was developed that protects both mice and guinea pigs from Lassa fever. The vaccine also elicits a lasting humoral response against both LASV and rabies virus in both animal models. The novel vaccine, which uses a rabies virus–derived vector, expresses a codon-optimized LASV glycoprotein, according to Tiago Abreu Mota, a doctoral student at Jefferson University, Philadelphia, and his colleagues.

CDC/C.S. Goldsmith

Lassa fever, a World Health Organization priority disease with a biosafety level of 4, is a hemorrhagic fever caused by the Lassa virus, which has no approved vaccine or potent antiviral treatment, according to the report published online in Nature Communications. So the development of a vaccine would be an important step in protecting the West African population from this deadly disease, which infects an estimated 100,000-300,000 people annually. As many as 80% of Lassa fever exposures are mildly symptomatic and thus go unreported; however, the case fatality rate of full-blown Lassa fever has been reported to reach as high as 50%, according to Mr. Mota and his colleagues.

An advantage to the new vaccine is that it is inactivated and thus could potentially be used in pregnant women and immunosuppressed patients, both of which are major risk groups for Lassa fever, according to the researchers. The vaccine could also protect against rabies, which is another major health concern in the regions affected by the Lassa virus.

In terms of mechanism of action, the vaccine did not induce virus-neutralizing antibodies, but rather appeared to trigger cell-mediated protection through activating natural killer cells to promote significantly more killing of virus-infected cells than nontriggered NK cells (P less than .01), as seen through in vitro testing.

The ability to assay for this form of vaccine effectiveness was a key development, according to the researchers. “The neutralizing antibody has been something of a gold standard in vaccine development. High levels are usually a good indication that the immune reaction is strong enough to deflect viral disease. In the case of Lassa virus, however, neutralizing antibodies have not been very good surrogates, since they are produced in much lower quantities. ... The new surrogate of protection will aid in the development of a more potent vaccine against Lassa virus,” according to a press release by Jefferson University.

This work was supported by various grants from the National Institutes of Health. Mr. Mota and two of his colleagues are inventors on a U.S. provisional patent application for a recombinant Lassa-rabies vaccine.

SOURCE: Mota TA et al. Nat Commun. 2018;9:4223. doi: 10.1038/s41467-018-06741-w.

 

An inactivated recombinant Lassa virus (LASV) and rabies vaccine candidate was developed that protects both mice and guinea pigs from Lassa fever. The vaccine also elicits a lasting humoral response against both LASV and rabies virus in both animal models. The novel vaccine, which uses a rabies virus–derived vector, expresses a codon-optimized LASV glycoprotein, according to Tiago Abreu Mota, a doctoral student at Jefferson University, Philadelphia, and his colleagues.

CDC/C.S. Goldsmith

Lassa fever, a World Health Organization priority disease with a biosafety level of 4, is a hemorrhagic fever caused by the Lassa virus, which has no approved vaccine or potent antiviral treatment, according to the report published online in Nature Communications. So the development of a vaccine would be an important step in protecting the West African population from this deadly disease, which infects an estimated 100,000-300,000 people annually. As many as 80% of Lassa fever exposures are mildly symptomatic and thus go unreported; however, the case fatality rate of full-blown Lassa fever has been reported to reach as high as 50%, according to Mr. Mota and his colleagues.

An advantage to the new vaccine is that it is inactivated and thus could potentially be used in pregnant women and immunosuppressed patients, both of which are major risk groups for Lassa fever, according to the researchers. The vaccine could also protect against rabies, which is another major health concern in the regions affected by the Lassa virus.

In terms of mechanism of action, the vaccine did not induce virus-neutralizing antibodies, but rather appeared to trigger cell-mediated protection through activating natural killer cells to promote significantly more killing of virus-infected cells than nontriggered NK cells (P less than .01), as seen through in vitro testing.

The ability to assay for this form of vaccine effectiveness was a key development, according to the researchers. “The neutralizing antibody has been something of a gold standard in vaccine development. High levels are usually a good indication that the immune reaction is strong enough to deflect viral disease. In the case of Lassa virus, however, neutralizing antibodies have not been very good surrogates, since they are produced in much lower quantities. ... The new surrogate of protection will aid in the development of a more potent vaccine against Lassa virus,” according to a press release by Jefferson University.

This work was supported by various grants from the National Institutes of Health. Mr. Mota and two of his colleagues are inventors on a U.S. provisional patent application for a recombinant Lassa-rabies vaccine.

SOURCE: Mota TA et al. Nat Commun. 2018;9:4223. doi: 10.1038/s41467-018-06741-w.

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Key clinical point: A novel recombinant Lassa virus vaccine protected guinea pigs and mice against Lassa fever.

Major finding: A novel recombinant Lassa virus vaccine elicited strong humeral antibody response in guinea pigs and mice against Lassa and rabies viruses.

Study details: Animal models and an in vitro cellular system were used to assay for the effectiveness of a novel Lassa fever vaccine.

Disclosures: This work was supported by grants from the National Institutes of Health. Mr. Mota and two of his colleagues are inventors on a U.S. provisional patent application for a recombinant Lassa-rabies vaccine.

Source: Mota TA et al. Nat Commun. 2018;9:4223. doi: 10.1038/s41467-018-06741-w.

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Experimental drugs deployed in Ebola response

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– For the first time, the World Health Organization’s Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) protocol is being field tested in the Democratic Republic of Congo (DRC), where four different therapeutics are being delivered to Ebola patients. MEURI was created after controversy surrounding the 2014-2016 Ebola outbreak in West Africa, which ultimately led to the decision to integrate research into outbreak responses.

gl0ck/Thinkstock

MEURI is broadly designed for pathogens that have no proven intervention, on the premise that in a disease with high mortality, it can be ethically appropriate to provide experimental therapies during a response, as long as a set of criteria are met that ensure patient autonomy and give patients a reasonable opportunity to improve their condition.

The original plan was to employ experimental drugs under the MEURI umbrella during an Ebola outbreak in the DRC that began in May, but an effective response contained it so quickly that the program was canceled. However, when another Ebola outbreak occurred on Aug. 27, the material was still in the country and ready to be deployed. “That made it very easy to begin using them,” said Elizabeth Higgs, MD, global health science advisor for the division of clinical research at the National Institute for Allergy and Infectious Disease.

Dr. Higgs spoke about the developments during a late-breakers session at IDWeek 2018, an annual scientific meeting on infectious disease.

The therapies under consideration are Zmapp (Leaf Biopharmaceutical), which includes three chimeric monoclonal antibodies that target the main surface protein of the Ebola virus; mAb114 (NIAID), which was isolated in 1995 from a human survivor of Ebola and binds to the core of the Ebola surface protein; Remdesivir (Gilead), a small molecule that is believed to interfere with viral replication; and Regeneron’s Ebola triple monoclonal antibody cocktail, which also targets the surface protein.

Through Oct. 2, 43 Ebola patients have received one of the four drugs: 19 are cured and have been discharged, 12 have died, and 12 are still in recovery. Dr. Higgs cautioned against reading anything into those numbers, however, since no randomization was involved.

Although compassionate use is the primary aim of MEURI, it may be lead to some scientific benefit. The most that can be hoped for is to glean some insight into the safety of the interventions, although even that information is limited. “A colleague and I were talking about this the other day. After the first X number of patients, they were all still alive. What can you say from that? I think what you can say is that it didn’t kill them,” Dr. Higgs said.

Still, researchers are collecting laboratory data from patients to monitor their responses. “With Remdesivir we’re closely examining their transaminase, for example, so I think it will be helpful,” said Dr. Higgs.

SOURCE: Higgs E et al. IDWeek 2018.

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– For the first time, the World Health Organization’s Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) protocol is being field tested in the Democratic Republic of Congo (DRC), where four different therapeutics are being delivered to Ebola patients. MEURI was created after controversy surrounding the 2014-2016 Ebola outbreak in West Africa, which ultimately led to the decision to integrate research into outbreak responses.

gl0ck/Thinkstock

MEURI is broadly designed for pathogens that have no proven intervention, on the premise that in a disease with high mortality, it can be ethically appropriate to provide experimental therapies during a response, as long as a set of criteria are met that ensure patient autonomy and give patients a reasonable opportunity to improve their condition.

The original plan was to employ experimental drugs under the MEURI umbrella during an Ebola outbreak in the DRC that began in May, but an effective response contained it so quickly that the program was canceled. However, when another Ebola outbreak occurred on Aug. 27, the material was still in the country and ready to be deployed. “That made it very easy to begin using them,” said Elizabeth Higgs, MD, global health science advisor for the division of clinical research at the National Institute for Allergy and Infectious Disease.

Dr. Higgs spoke about the developments during a late-breakers session at IDWeek 2018, an annual scientific meeting on infectious disease.

The therapies under consideration are Zmapp (Leaf Biopharmaceutical), which includes three chimeric monoclonal antibodies that target the main surface protein of the Ebola virus; mAb114 (NIAID), which was isolated in 1995 from a human survivor of Ebola and binds to the core of the Ebola surface protein; Remdesivir (Gilead), a small molecule that is believed to interfere with viral replication; and Regeneron’s Ebola triple monoclonal antibody cocktail, which also targets the surface protein.

Through Oct. 2, 43 Ebola patients have received one of the four drugs: 19 are cured and have been discharged, 12 have died, and 12 are still in recovery. Dr. Higgs cautioned against reading anything into those numbers, however, since no randomization was involved.

Although compassionate use is the primary aim of MEURI, it may be lead to some scientific benefit. The most that can be hoped for is to glean some insight into the safety of the interventions, although even that information is limited. “A colleague and I were talking about this the other day. After the first X number of patients, they were all still alive. What can you say from that? I think what you can say is that it didn’t kill them,” Dr. Higgs said.

Still, researchers are collecting laboratory data from patients to monitor their responses. “With Remdesivir we’re closely examining their transaminase, for example, so I think it will be helpful,” said Dr. Higgs.

SOURCE: Higgs E et al. IDWeek 2018.

– For the first time, the World Health Organization’s Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) protocol is being field tested in the Democratic Republic of Congo (DRC), where four different therapeutics are being delivered to Ebola patients. MEURI was created after controversy surrounding the 2014-2016 Ebola outbreak in West Africa, which ultimately led to the decision to integrate research into outbreak responses.

gl0ck/Thinkstock

MEURI is broadly designed for pathogens that have no proven intervention, on the premise that in a disease with high mortality, it can be ethically appropriate to provide experimental therapies during a response, as long as a set of criteria are met that ensure patient autonomy and give patients a reasonable opportunity to improve their condition.

The original plan was to employ experimental drugs under the MEURI umbrella during an Ebola outbreak in the DRC that began in May, but an effective response contained it so quickly that the program was canceled. However, when another Ebola outbreak occurred on Aug. 27, the material was still in the country and ready to be deployed. “That made it very easy to begin using them,” said Elizabeth Higgs, MD, global health science advisor for the division of clinical research at the National Institute for Allergy and Infectious Disease.

Dr. Higgs spoke about the developments during a late-breakers session at IDWeek 2018, an annual scientific meeting on infectious disease.

The therapies under consideration are Zmapp (Leaf Biopharmaceutical), which includes three chimeric monoclonal antibodies that target the main surface protein of the Ebola virus; mAb114 (NIAID), which was isolated in 1995 from a human survivor of Ebola and binds to the core of the Ebola surface protein; Remdesivir (Gilead), a small molecule that is believed to interfere with viral replication; and Regeneron’s Ebola triple monoclonal antibody cocktail, which also targets the surface protein.

Through Oct. 2, 43 Ebola patients have received one of the four drugs: 19 are cured and have been discharged, 12 have died, and 12 are still in recovery. Dr. Higgs cautioned against reading anything into those numbers, however, since no randomization was involved.

Although compassionate use is the primary aim of MEURI, it may be lead to some scientific benefit. The most that can be hoped for is to glean some insight into the safety of the interventions, although even that information is limited. “A colleague and I were talking about this the other day. After the first X number of patients, they were all still alive. What can you say from that? I think what you can say is that it didn’t kill them,” Dr. Higgs said.

Still, researchers are collecting laboratory data from patients to monitor their responses. “With Remdesivir we’re closely examining their transaminase, for example, so I think it will be helpful,” said Dr. Higgs.

SOURCE: Higgs E et al. IDWeek 2018.

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REPORTING FROM ID WEEK 2018

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Key clinical point: A total of 19 patients with Ebola were cured and have been discharged; 12 have died, and 12 are in recovery.

Major finding: Since Oct. 2, 43 Ebola patients have received one of the four drugs: 19 were cured; 12 died, and 12 are in recovery.

Study details: Therapies are Zmapp (Leaf Biopharmaceutical), mAb114 (NIAID), Remdesivir (Gilead), and Regeneron’s Ebola triple monoclonal antibody cocktail.

Disclosures: Dr. Higgs reported no conflicts of interest.

Source: Higgs E et al. ID Week 2018.

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NYC outbreak of Candida auris linked to 45% mortality

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NYC outbreak of Candida auris linked to 45% mortality

Mortality within 90 days of infection was 45% among 51 patients diagnosed with antibiotic-resistant Candida auris infections in a multihospital outbreak in New York City from 2012 to 2017.

Transmission is ongoing in health care facilities, primarily among patients with extensive health care exposures, according to a report published in Emerging Infectious Diseases.

Shawn Lockhart/CDC
This image depicts a strain of Candida auris cultured in a petri dish.

“Intensive infection prevention and control efforts continue; the goals are delaying endemicity, preventing outbreaks within facilities, reducing transmission and geographic spread, and blunting the effect of C. auris in New York and the rest of the United States,” Eleanor Adams, MD, of the New York Health Department, and her colleagues wrote. “Among medically fragile patients in NYC who had a history of extensive contact with health care facilities, clinicians should include C. auris in the differential diagnosis for patients with symptoms compatible with bloodstream infection.”


In the intensive case-patient analysis conducted by the New York State Health Department, 21 cases were from seven hospitals in Brooklyn, 16 were from three hospitals and one private medical office in Queens, 12 were from five hospitals and one long-term acute care hospital in Manhattan, and 1 was from a hospital in the Bronx. The remaining clinical case was identified in a western New York hospital in a patient who had recently been admitted to an involved Brooklyn hospital.


Among these patients, 31 (61%) had resided in long-term care facilities immediately before being admitted to the hospital in which their infection was diagnosed, and 19 of these 31 resided in skilled nursing facilities with ventilator beds; 1 (2%) resided in a long-term acute care hospital; 5 (10%) had been transferred from another hospital; and 4 (8%) had traveled internationally within 5 years before diagnosis, according to the investigators.

Isolates from 50 patients (98%) were resistant to fluconazole and 13 (25%) were resistant to fluconazole and amphotericin B. No initial isolates were resistant to echinocandins, although subsequent isolates obtained from 3 persons who had received an echinocandin acquired resistance to it, according to the researchers. Whole-genome sequencing performed at The Centers for Disease Control and Prevention indicated that 50 of 51 isolates belonged to a South Asia clade; the remaining isolate was the only one susceptible to fluconazole.

The work was supported by the CDC. No disclosures were reported.

SOURCE: Adams E et al. Emerg Infect Dis. 2018 Sep 12; 24(10); ID: 18-0649.

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Mortality within 90 days of infection was 45% among 51 patients diagnosed with antibiotic-resistant Candida auris infections in a multihospital outbreak in New York City from 2012 to 2017.

Transmission is ongoing in health care facilities, primarily among patients with extensive health care exposures, according to a report published in Emerging Infectious Diseases.

Shawn Lockhart/CDC
This image depicts a strain of Candida auris cultured in a petri dish.

“Intensive infection prevention and control efforts continue; the goals are delaying endemicity, preventing outbreaks within facilities, reducing transmission and geographic spread, and blunting the effect of C. auris in New York and the rest of the United States,” Eleanor Adams, MD, of the New York Health Department, and her colleagues wrote. “Among medically fragile patients in NYC who had a history of extensive contact with health care facilities, clinicians should include C. auris in the differential diagnosis for patients with symptoms compatible with bloodstream infection.”


In the intensive case-patient analysis conducted by the New York State Health Department, 21 cases were from seven hospitals in Brooklyn, 16 were from three hospitals and one private medical office in Queens, 12 were from five hospitals and one long-term acute care hospital in Manhattan, and 1 was from a hospital in the Bronx. The remaining clinical case was identified in a western New York hospital in a patient who had recently been admitted to an involved Brooklyn hospital.


Among these patients, 31 (61%) had resided in long-term care facilities immediately before being admitted to the hospital in which their infection was diagnosed, and 19 of these 31 resided in skilled nursing facilities with ventilator beds; 1 (2%) resided in a long-term acute care hospital; 5 (10%) had been transferred from another hospital; and 4 (8%) had traveled internationally within 5 years before diagnosis, according to the investigators.

Isolates from 50 patients (98%) were resistant to fluconazole and 13 (25%) were resistant to fluconazole and amphotericin B. No initial isolates were resistant to echinocandins, although subsequent isolates obtained from 3 persons who had received an echinocandin acquired resistance to it, according to the researchers. Whole-genome sequencing performed at The Centers for Disease Control and Prevention indicated that 50 of 51 isolates belonged to a South Asia clade; the remaining isolate was the only one susceptible to fluconazole.

The work was supported by the CDC. No disclosures were reported.

SOURCE: Adams E et al. Emerg Infect Dis. 2018 Sep 12; 24(10); ID: 18-0649.

Mortality within 90 days of infection was 45% among 51 patients diagnosed with antibiotic-resistant Candida auris infections in a multihospital outbreak in New York City from 2012 to 2017.

Transmission is ongoing in health care facilities, primarily among patients with extensive health care exposures, according to a report published in Emerging Infectious Diseases.

Shawn Lockhart/CDC
This image depicts a strain of Candida auris cultured in a petri dish.

“Intensive infection prevention and control efforts continue; the goals are delaying endemicity, preventing outbreaks within facilities, reducing transmission and geographic spread, and blunting the effect of C. auris in New York and the rest of the United States,” Eleanor Adams, MD, of the New York Health Department, and her colleagues wrote. “Among medically fragile patients in NYC who had a history of extensive contact with health care facilities, clinicians should include C. auris in the differential diagnosis for patients with symptoms compatible with bloodstream infection.”


In the intensive case-patient analysis conducted by the New York State Health Department, 21 cases were from seven hospitals in Brooklyn, 16 were from three hospitals and one private medical office in Queens, 12 were from five hospitals and one long-term acute care hospital in Manhattan, and 1 was from a hospital in the Bronx. The remaining clinical case was identified in a western New York hospital in a patient who had recently been admitted to an involved Brooklyn hospital.


Among these patients, 31 (61%) had resided in long-term care facilities immediately before being admitted to the hospital in which their infection was diagnosed, and 19 of these 31 resided in skilled nursing facilities with ventilator beds; 1 (2%) resided in a long-term acute care hospital; 5 (10%) had been transferred from another hospital; and 4 (8%) had traveled internationally within 5 years before diagnosis, according to the investigators.

Isolates from 50 patients (98%) were resistant to fluconazole and 13 (25%) were resistant to fluconazole and amphotericin B. No initial isolates were resistant to echinocandins, although subsequent isolates obtained from 3 persons who had received an echinocandin acquired resistance to it, according to the researchers. Whole-genome sequencing performed at The Centers for Disease Control and Prevention indicated that 50 of 51 isolates belonged to a South Asia clade; the remaining isolate was the only one susceptible to fluconazole.

The work was supported by the CDC. No disclosures were reported.

SOURCE: Adams E et al. Emerg Infect Dis. 2018 Sep 12; 24(10); ID: 18-0649.

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Outpatient costs soar for Medicare patients with chronic hepatitis B

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Sat, 12/08/2018 - 15:19

The average cost of outpatient care for Medicare recipients with chronic hepatitis B (CH-B) rose by 400% from 2005 to 2014, according to investigators.

utah778/Thinkstock

Inpatient costs also increased, although less dramatically, reported lead author Min Kim, MD, of the Inova Fairfax Hospital Center for Liver Diseases in Falls Church, Virginia, and her colleagues. The causes of these spending hikes may range from policy changes and expanded screening to an aging immigrant population.

“According to the National Health and Nutrition Examination Survey, from 1988 to 2012 most people with CH-B in the United States were foreign born and accounted for up to 70% of all CH-B infections,” the authors wrote in the Journal of Clinical Gastroenterology. “The Centers for Disease Control [and Prevention] estimates that Asians, who comprise 5% of the U.S. population, account for 50% of all chronic CH-B infections.” Despite these statistics, the clinical and economic impacts of an aging immigrant population are unknown. The investigators therefore assessed patient characteristics associated with increased 1-year mortality and the impact of demographic changes on Medicare costs.

The retrospective study began with a random sample of Medicare beneficiaries from 2005 to 2014. From this group, 18,603 patients with CH-B were identified by ICD-9 codes V02.61, 070.2, 070.3, 070.42, and 070.52. Patients with ICD-9-CM codes of 197.7, 155.1, or 155.2 were excluded, as were records containing insufficient information about year, region, or race. Patients were analyzed collectively and as inpatients (n = 6,550) or outpatients (n = 13,648).

Cost of care (per patient, per year) and 1-year mortality were evaluated. Patient characteristics included age, sex, race/ethnicity, geographic region, type of Medicare eligibility, length of stay, Charlson comorbidity index, presence of decompensated cirrhosis, and/or hepatocellular carcinoma (HCC).

Most dramatically, outpatient charges rose more than 400% during the study period, from $9,257 in 2005 to $47,864 in 2014 (P less than .001). Inpatient charges increased by almost 50%, from $66,610 to $94,221 (P less than .001). (All values converted to 2016 dollars.)

Although the increase in outpatient costs appears seismic, the authors noted that costs held steady from 2005 to 2010 before spiking dramatically, reaching a peak of $58,450 in 2013 before settling down to $47,864 the following year. This spike may be caused by changes in screening measures and policies. In 2009, the American Association for the Study of Liver Diseases expanded screening guidelines to include previously ineligible patients with CH-B, and in 2010, the Centers for Medicare & Medicaid Services expanded ICD-9 and ICD-10 codes for CH-B from 9 to 25.

“It seems plausible that the increase in CH-B prevalence, and its associated costs, might actually be a reflection of [these factors],” the authors noted. Still, “additional studies are needed to clarify this observation.”

Turning to patient characteristics, the authors reported that 1-year mortality was independently associated most strongly with decompensated cirrhosis (odds ratio, 3.02) and hepatocellular carcinoma (OR, 2.64). In comparison with white patients, Asians were less likely to die (OR, 0.47).

“It is possible that this can be explained through differences in transmission mode and disease progression of CH-B between these two demographics,” the authors wrote. “A majority of Asian Medicare recipients with CH-B likely acquired it perinatally and did not develop significant liver disease. In contrast, whites with CH-B generally acquired it in adulthood, increasing the chance of developing liver disease.”

Over the 10-year study period, Medicare beneficiaries with CH-B became more frequently Asian and less frequently male. While the number of outpatient visits and average Charlson comorbidity index increased, decreases were reported for length of stay, rates of 1-year mortality, hospitalization, and HCC – the latter of which is most closely associated with higher costs of care.

The investigators suggested that the decreased incidence of HCC was caused by “better screening programs for HCC and/or more widespread use of antiviral treatment for CH-B.”

“Although advances in antiviral treatment have effectively reduced hospitalization and disease progression,” the authors wrote, “vulnerable groups – especially immigrants and individuals living in poverty – present an important challenge for better identification of infected individuals and their linkage to care. In this context, it is vital to target these cohorts to reduce further mortality and resource utilization, as well as optimize long-term public health and financial benefits.”

Study funding was provided by Seattle Genetics. One coauthor reported compensation from Gilead Sciences, AbbVie, Intercept Pharmaceuticals, GlaxoSmithKline, and Bristol-Myers Squibb.

SOURCE: Kim M et al. J Clin Gastro. 2018 Aug 13. doi: 10.1097/MCG.0000000000001110.

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The average cost of outpatient care for Medicare recipients with chronic hepatitis B (CH-B) rose by 400% from 2005 to 2014, according to investigators.

utah778/Thinkstock

Inpatient costs also increased, although less dramatically, reported lead author Min Kim, MD, of the Inova Fairfax Hospital Center for Liver Diseases in Falls Church, Virginia, and her colleagues. The causes of these spending hikes may range from policy changes and expanded screening to an aging immigrant population.

“According to the National Health and Nutrition Examination Survey, from 1988 to 2012 most people with CH-B in the United States were foreign born and accounted for up to 70% of all CH-B infections,” the authors wrote in the Journal of Clinical Gastroenterology. “The Centers for Disease Control [and Prevention] estimates that Asians, who comprise 5% of the U.S. population, account for 50% of all chronic CH-B infections.” Despite these statistics, the clinical and economic impacts of an aging immigrant population are unknown. The investigators therefore assessed patient characteristics associated with increased 1-year mortality and the impact of demographic changes on Medicare costs.

The retrospective study began with a random sample of Medicare beneficiaries from 2005 to 2014. From this group, 18,603 patients with CH-B were identified by ICD-9 codes V02.61, 070.2, 070.3, 070.42, and 070.52. Patients with ICD-9-CM codes of 197.7, 155.1, or 155.2 were excluded, as were records containing insufficient information about year, region, or race. Patients were analyzed collectively and as inpatients (n = 6,550) or outpatients (n = 13,648).

Cost of care (per patient, per year) and 1-year mortality were evaluated. Patient characteristics included age, sex, race/ethnicity, geographic region, type of Medicare eligibility, length of stay, Charlson comorbidity index, presence of decompensated cirrhosis, and/or hepatocellular carcinoma (HCC).

Most dramatically, outpatient charges rose more than 400% during the study period, from $9,257 in 2005 to $47,864 in 2014 (P less than .001). Inpatient charges increased by almost 50%, from $66,610 to $94,221 (P less than .001). (All values converted to 2016 dollars.)

Although the increase in outpatient costs appears seismic, the authors noted that costs held steady from 2005 to 2010 before spiking dramatically, reaching a peak of $58,450 in 2013 before settling down to $47,864 the following year. This spike may be caused by changes in screening measures and policies. In 2009, the American Association for the Study of Liver Diseases expanded screening guidelines to include previously ineligible patients with CH-B, and in 2010, the Centers for Medicare & Medicaid Services expanded ICD-9 and ICD-10 codes for CH-B from 9 to 25.

“It seems plausible that the increase in CH-B prevalence, and its associated costs, might actually be a reflection of [these factors],” the authors noted. Still, “additional studies are needed to clarify this observation.”

Turning to patient characteristics, the authors reported that 1-year mortality was independently associated most strongly with decompensated cirrhosis (odds ratio, 3.02) and hepatocellular carcinoma (OR, 2.64). In comparison with white patients, Asians were less likely to die (OR, 0.47).

“It is possible that this can be explained through differences in transmission mode and disease progression of CH-B between these two demographics,” the authors wrote. “A majority of Asian Medicare recipients with CH-B likely acquired it perinatally and did not develop significant liver disease. In contrast, whites with CH-B generally acquired it in adulthood, increasing the chance of developing liver disease.”

Over the 10-year study period, Medicare beneficiaries with CH-B became more frequently Asian and less frequently male. While the number of outpatient visits and average Charlson comorbidity index increased, decreases were reported for length of stay, rates of 1-year mortality, hospitalization, and HCC – the latter of which is most closely associated with higher costs of care.

The investigators suggested that the decreased incidence of HCC was caused by “better screening programs for HCC and/or more widespread use of antiviral treatment for CH-B.”

“Although advances in antiviral treatment have effectively reduced hospitalization and disease progression,” the authors wrote, “vulnerable groups – especially immigrants and individuals living in poverty – present an important challenge for better identification of infected individuals and their linkage to care. In this context, it is vital to target these cohorts to reduce further mortality and resource utilization, as well as optimize long-term public health and financial benefits.”

Study funding was provided by Seattle Genetics. One coauthor reported compensation from Gilead Sciences, AbbVie, Intercept Pharmaceuticals, GlaxoSmithKline, and Bristol-Myers Squibb.

SOURCE: Kim M et al. J Clin Gastro. 2018 Aug 13. doi: 10.1097/MCG.0000000000001110.

The average cost of outpatient care for Medicare recipients with chronic hepatitis B (CH-B) rose by 400% from 2005 to 2014, according to investigators.

utah778/Thinkstock

Inpatient costs also increased, although less dramatically, reported lead author Min Kim, MD, of the Inova Fairfax Hospital Center for Liver Diseases in Falls Church, Virginia, and her colleagues. The causes of these spending hikes may range from policy changes and expanded screening to an aging immigrant population.

“According to the National Health and Nutrition Examination Survey, from 1988 to 2012 most people with CH-B in the United States were foreign born and accounted for up to 70% of all CH-B infections,” the authors wrote in the Journal of Clinical Gastroenterology. “The Centers for Disease Control [and Prevention] estimates that Asians, who comprise 5% of the U.S. population, account for 50% of all chronic CH-B infections.” Despite these statistics, the clinical and economic impacts of an aging immigrant population are unknown. The investigators therefore assessed patient characteristics associated with increased 1-year mortality and the impact of demographic changes on Medicare costs.

The retrospective study began with a random sample of Medicare beneficiaries from 2005 to 2014. From this group, 18,603 patients with CH-B were identified by ICD-9 codes V02.61, 070.2, 070.3, 070.42, and 070.52. Patients with ICD-9-CM codes of 197.7, 155.1, or 155.2 were excluded, as were records containing insufficient information about year, region, or race. Patients were analyzed collectively and as inpatients (n = 6,550) or outpatients (n = 13,648).

Cost of care (per patient, per year) and 1-year mortality were evaluated. Patient characteristics included age, sex, race/ethnicity, geographic region, type of Medicare eligibility, length of stay, Charlson comorbidity index, presence of decompensated cirrhosis, and/or hepatocellular carcinoma (HCC).

Most dramatically, outpatient charges rose more than 400% during the study period, from $9,257 in 2005 to $47,864 in 2014 (P less than .001). Inpatient charges increased by almost 50%, from $66,610 to $94,221 (P less than .001). (All values converted to 2016 dollars.)

Although the increase in outpatient costs appears seismic, the authors noted that costs held steady from 2005 to 2010 before spiking dramatically, reaching a peak of $58,450 in 2013 before settling down to $47,864 the following year. This spike may be caused by changes in screening measures and policies. In 2009, the American Association for the Study of Liver Diseases expanded screening guidelines to include previously ineligible patients with CH-B, and in 2010, the Centers for Medicare & Medicaid Services expanded ICD-9 and ICD-10 codes for CH-B from 9 to 25.

“It seems plausible that the increase in CH-B prevalence, and its associated costs, might actually be a reflection of [these factors],” the authors noted. Still, “additional studies are needed to clarify this observation.”

Turning to patient characteristics, the authors reported that 1-year mortality was independently associated most strongly with decompensated cirrhosis (odds ratio, 3.02) and hepatocellular carcinoma (OR, 2.64). In comparison with white patients, Asians were less likely to die (OR, 0.47).

“It is possible that this can be explained through differences in transmission mode and disease progression of CH-B between these two demographics,” the authors wrote. “A majority of Asian Medicare recipients with CH-B likely acquired it perinatally and did not develop significant liver disease. In contrast, whites with CH-B generally acquired it in adulthood, increasing the chance of developing liver disease.”

Over the 10-year study period, Medicare beneficiaries with CH-B became more frequently Asian and less frequently male. While the number of outpatient visits and average Charlson comorbidity index increased, decreases were reported for length of stay, rates of 1-year mortality, hospitalization, and HCC – the latter of which is most closely associated with higher costs of care.

The investigators suggested that the decreased incidence of HCC was caused by “better screening programs for HCC and/or more widespread use of antiviral treatment for CH-B.”

“Although advances in antiviral treatment have effectively reduced hospitalization and disease progression,” the authors wrote, “vulnerable groups – especially immigrants and individuals living in poverty – present an important challenge for better identification of infected individuals and their linkage to care. In this context, it is vital to target these cohorts to reduce further mortality and resource utilization, as well as optimize long-term public health and financial benefits.”

Study funding was provided by Seattle Genetics. One coauthor reported compensation from Gilead Sciences, AbbVie, Intercept Pharmaceuticals, GlaxoSmithKline, and Bristol-Myers Squibb.

SOURCE: Kim M et al. J Clin Gastro. 2018 Aug 13. doi: 10.1097/MCG.0000000000001110.

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Key clinical point: Outpatient care for patients with chronic hepatitis B is becoming more expensive; the trend may be tied to an aging immigrant population.

Major finding: The average Medicare charge for outpatient care per patient increased from $9,257 in 2005 to $47,864 in 2014 (P less than .001).

Study details: A retrospective study involving 18,603 Medicare recipients with chronic hepatitis B who filed claims between 2005 and 2014.

Disclosures: Study funding was provided by the Beatty Center for Integrated Research. One coauthor reported compensation from Gilead Sciences, AbbVie, Intercept Pharmaceuticals, GlaxoSmithKline, and Bristol-Myers Squibb.

Source: Kim M et al. J Clin Gastro. 2018 Aug 13. doi: 10.1097/MCG.0000000000001110.

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AHA: Chagas disease and its heart effects have come to the U.S.

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Sat, 12/08/2018 - 15:16

 

Chagas disease, a cause of serious cardiovascular problems and sudden death, was previously localized mainly in the tropics, but now affects at least 300,000 people in the United States and is growing in prevalence in other traditionally nonendemic areas, including Europe, Australia, and Japan. The American Heart Association and the Inter-American Society of Cardiology have released a statement to “increase global awareness among providers who may encounter patients with Chagas disease outside of traditionally endemic environments.”

Dr. Mae Melvin/CDC

The document summarizes the most up-to-date information on diagnosis, screening, and treatment of Trypanosoma cruzi (the protozoan cause of Chagas) infection, focusing primarily on its cardiovascular aspects, and was developed by Maria Carmo Pereira Nunes, MD, chair, and her colleagues on the American Heart Association Rheumatic Fever, Endocarditis and Kawasaki Disease Committee.

Chagas disease is transmitted by a blood-sucking insect vector Triatoma infestans and, less frequently, from mother to fetus or by contaminated food or drink, and about one third of infected individuals develop chronic heart disease.

Although 60%-70% of people infected with T. cruzi never develop any symptoms, those who do can develop heart disease, including heart failure, stroke, life threatening ventricular arrhythmias, and cardiac arrest, according to the statement published in Circulation.

Chronic Chagas-related heart disease develops after several decades of the indeterminate, or subclinical, form of the disease following the initial acute infection. Potential risk factors for progression to the chronic stage include African ancestry, age, severity of acute infection, nutritional status, alcoholism, and their concomitant diseases.

In most studies, sudden death is the most common overall cause of death in patients with Chagas-related cardiomyopathy (55%-60%), followed by heart failure (25%-30%) and embolic events (10%-15%), according to the authors.

Benznidazole and nifurtimox are the only drugs with proven efficacy against Chagas disease, with benznidazole as the first-line treatment because it has better tolerance, is more widely available, and has more published data published on its efficacy. Furthermore, it is available in the United States, after the Food and Drug Administration granted fast-track approved 2017 for treatment of Chagas disease. Use of nifurtimox in the United States entails consultation with the Centers for Disease Control and prevention, according to the statement.

“More data are needed on the best practices for the treatment of Chagas cardiomyopathy. Because no specific clinical trials have been conducted, care for

patients with Chagas-induced ventricular dysfunction is extrapolated from general heart failure recommendations with unclear efficacy (and potential harm),” Dr. Pereira Nunes and her colleagues concluded.

One author disclosed receiving a research grant from Merck and speakers’ bureau and/or honoraria from Bayer; Biotronik, and Medtronic. The others had no relevant disclosures.

SOURCE: Nunes, MCP, et al., Circulation. 2018 Aug 20; doi: 10.1161/CIR.0000000000000599.

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Chagas disease, a cause of serious cardiovascular problems and sudden death, was previously localized mainly in the tropics, but now affects at least 300,000 people in the United States and is growing in prevalence in other traditionally nonendemic areas, including Europe, Australia, and Japan. The American Heart Association and the Inter-American Society of Cardiology have released a statement to “increase global awareness among providers who may encounter patients with Chagas disease outside of traditionally endemic environments.”

Dr. Mae Melvin/CDC

The document summarizes the most up-to-date information on diagnosis, screening, and treatment of Trypanosoma cruzi (the protozoan cause of Chagas) infection, focusing primarily on its cardiovascular aspects, and was developed by Maria Carmo Pereira Nunes, MD, chair, and her colleagues on the American Heart Association Rheumatic Fever, Endocarditis and Kawasaki Disease Committee.

Chagas disease is transmitted by a blood-sucking insect vector Triatoma infestans and, less frequently, from mother to fetus or by contaminated food or drink, and about one third of infected individuals develop chronic heart disease.

Although 60%-70% of people infected with T. cruzi never develop any symptoms, those who do can develop heart disease, including heart failure, stroke, life threatening ventricular arrhythmias, and cardiac arrest, according to the statement published in Circulation.

Chronic Chagas-related heart disease develops after several decades of the indeterminate, or subclinical, form of the disease following the initial acute infection. Potential risk factors for progression to the chronic stage include African ancestry, age, severity of acute infection, nutritional status, alcoholism, and their concomitant diseases.

In most studies, sudden death is the most common overall cause of death in patients with Chagas-related cardiomyopathy (55%-60%), followed by heart failure (25%-30%) and embolic events (10%-15%), according to the authors.

Benznidazole and nifurtimox are the only drugs with proven efficacy against Chagas disease, with benznidazole as the first-line treatment because it has better tolerance, is more widely available, and has more published data published on its efficacy. Furthermore, it is available in the United States, after the Food and Drug Administration granted fast-track approved 2017 for treatment of Chagas disease. Use of nifurtimox in the United States entails consultation with the Centers for Disease Control and prevention, according to the statement.

“More data are needed on the best practices for the treatment of Chagas cardiomyopathy. Because no specific clinical trials have been conducted, care for

patients with Chagas-induced ventricular dysfunction is extrapolated from general heart failure recommendations with unclear efficacy (and potential harm),” Dr. Pereira Nunes and her colleagues concluded.

One author disclosed receiving a research grant from Merck and speakers’ bureau and/or honoraria from Bayer; Biotronik, and Medtronic. The others had no relevant disclosures.

SOURCE: Nunes, MCP, et al., Circulation. 2018 Aug 20; doi: 10.1161/CIR.0000000000000599.

 

Chagas disease, a cause of serious cardiovascular problems and sudden death, was previously localized mainly in the tropics, but now affects at least 300,000 people in the United States and is growing in prevalence in other traditionally nonendemic areas, including Europe, Australia, and Japan. The American Heart Association and the Inter-American Society of Cardiology have released a statement to “increase global awareness among providers who may encounter patients with Chagas disease outside of traditionally endemic environments.”

Dr. Mae Melvin/CDC

The document summarizes the most up-to-date information on diagnosis, screening, and treatment of Trypanosoma cruzi (the protozoan cause of Chagas) infection, focusing primarily on its cardiovascular aspects, and was developed by Maria Carmo Pereira Nunes, MD, chair, and her colleagues on the American Heart Association Rheumatic Fever, Endocarditis and Kawasaki Disease Committee.

Chagas disease is transmitted by a blood-sucking insect vector Triatoma infestans and, less frequently, from mother to fetus or by contaminated food or drink, and about one third of infected individuals develop chronic heart disease.

Although 60%-70% of people infected with T. cruzi never develop any symptoms, those who do can develop heart disease, including heart failure, stroke, life threatening ventricular arrhythmias, and cardiac arrest, according to the statement published in Circulation.

Chronic Chagas-related heart disease develops after several decades of the indeterminate, or subclinical, form of the disease following the initial acute infection. Potential risk factors for progression to the chronic stage include African ancestry, age, severity of acute infection, nutritional status, alcoholism, and their concomitant diseases.

In most studies, sudden death is the most common overall cause of death in patients with Chagas-related cardiomyopathy (55%-60%), followed by heart failure (25%-30%) and embolic events (10%-15%), according to the authors.

Benznidazole and nifurtimox are the only drugs with proven efficacy against Chagas disease, with benznidazole as the first-line treatment because it has better tolerance, is more widely available, and has more published data published on its efficacy. Furthermore, it is available in the United States, after the Food and Drug Administration granted fast-track approved 2017 for treatment of Chagas disease. Use of nifurtimox in the United States entails consultation with the Centers for Disease Control and prevention, according to the statement.

“More data are needed on the best practices for the treatment of Chagas cardiomyopathy. Because no specific clinical trials have been conducted, care for

patients with Chagas-induced ventricular dysfunction is extrapolated from general heart failure recommendations with unclear efficacy (and potential harm),” Dr. Pereira Nunes and her colleagues concluded.

One author disclosed receiving a research grant from Merck and speakers’ bureau and/or honoraria from Bayer; Biotronik, and Medtronic. The others had no relevant disclosures.

SOURCE: Nunes, MCP, et al., Circulation. 2018 Aug 20; doi: 10.1161/CIR.0000000000000599.

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Zika virus vaccine trial launches

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Fri, 01/18/2019 - 17:53

 

A first-in-human trial of a live, attenuated Zika virus vaccine has begun, according to an announcement by the National Institutes of Health.

Courtesy National Institute of Allergy and Infectious Diseases
Zika virus particles (red) shown in African green monkey kidney cells.


The vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases will be tested in 28 healthy, nonpregnant adults aged 18-50 years at two centers, the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore, and the Vaccine Testing Center at the University of Vermont in Burlington.

The challenge virus in the vaccine is an attenuated genetic chimera consisting of a dengue virus 4 backbone that expresses Zika virus surface proteins designed to elicit an immune response. The virus was previously tested in rhesus macaque monkeys.

Study participants for the phase 1 trial, Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-Naive Adults, (NCT03611946) will be assessed based on local and general adverse events to the vaccine and peak neutralizing antibody titer to Zika virus as measured up to 90 days after vaccination. The trial is expected to be reach primary completion by Dec. 31, 2018.

If the phase 1 trial is successful, the goal is to integrate the vaccine with a live, attenuated dengue vaccine candidate called TV003, which is designed to elicit antibodies against all four dengue virus serotypes. The TV003 experimental vaccine is currently under evaluation in a phase 3 clinical trial (NCT02406729) underway in Brazil. Both Zika and dengue viruses frequently are endemic in the same regions and a single vaccine against both diseases would be valued. Stephen Whitehead, PhD of NIAID’s Laboratory of Viral Diseases led the efforts to develop both experimental vaccines.
 

SOURCE: NIH, August 16, 2018. News Release.

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A first-in-human trial of a live, attenuated Zika virus vaccine has begun, according to an announcement by the National Institutes of Health.

Courtesy National Institute of Allergy and Infectious Diseases
Zika virus particles (red) shown in African green monkey kidney cells.


The vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases will be tested in 28 healthy, nonpregnant adults aged 18-50 years at two centers, the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore, and the Vaccine Testing Center at the University of Vermont in Burlington.

The challenge virus in the vaccine is an attenuated genetic chimera consisting of a dengue virus 4 backbone that expresses Zika virus surface proteins designed to elicit an immune response. The virus was previously tested in rhesus macaque monkeys.

Study participants for the phase 1 trial, Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-Naive Adults, (NCT03611946) will be assessed based on local and general adverse events to the vaccine and peak neutralizing antibody titer to Zika virus as measured up to 90 days after vaccination. The trial is expected to be reach primary completion by Dec. 31, 2018.

If the phase 1 trial is successful, the goal is to integrate the vaccine with a live, attenuated dengue vaccine candidate called TV003, which is designed to elicit antibodies against all four dengue virus serotypes. The TV003 experimental vaccine is currently under evaluation in a phase 3 clinical trial (NCT02406729) underway in Brazil. Both Zika and dengue viruses frequently are endemic in the same regions and a single vaccine against both diseases would be valued. Stephen Whitehead, PhD of NIAID’s Laboratory of Viral Diseases led the efforts to develop both experimental vaccines.
 

SOURCE: NIH, August 16, 2018. News Release.

 

A first-in-human trial of a live, attenuated Zika virus vaccine has begun, according to an announcement by the National Institutes of Health.

Courtesy National Institute of Allergy and Infectious Diseases
Zika virus particles (red) shown in African green monkey kidney cells.


The vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases will be tested in 28 healthy, nonpregnant adults aged 18-50 years at two centers, the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore, and the Vaccine Testing Center at the University of Vermont in Burlington.

The challenge virus in the vaccine is an attenuated genetic chimera consisting of a dengue virus 4 backbone that expresses Zika virus surface proteins designed to elicit an immune response. The virus was previously tested in rhesus macaque monkeys.

Study participants for the phase 1 trial, Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-Naive Adults, (NCT03611946) will be assessed based on local and general adverse events to the vaccine and peak neutralizing antibody titer to Zika virus as measured up to 90 days after vaccination. The trial is expected to be reach primary completion by Dec. 31, 2018.

If the phase 1 trial is successful, the goal is to integrate the vaccine with a live, attenuated dengue vaccine candidate called TV003, which is designed to elicit antibodies against all four dengue virus serotypes. The TV003 experimental vaccine is currently under evaluation in a phase 3 clinical trial (NCT02406729) underway in Brazil. Both Zika and dengue viruses frequently are endemic in the same regions and a single vaccine against both diseases would be valued. Stephen Whitehead, PhD of NIAID’s Laboratory of Viral Diseases led the efforts to develop both experimental vaccines.
 

SOURCE: NIH, August 16, 2018. News Release.

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