Healthcare-acquired Infections

PHOENIX – If you happen to believe that the impact of health care–acquired infections is insignificant, think again. According to Dr. Kevin W. Lobdell, health care–acquired infections (HAIs) cause more deaths each year in the United States than breast cancer, lung cancer, and AIDS combined.

“If you look at hospitalized patients, one in five will acquire a health care–acquired infection,” Dr. Lobdell of the Sanger Heart and Vascular Institute at Carolinas Health System, Charlotte, N.C., said in a video interview at the annual meeting of the Society of Thoracic Surgeons. “With respect to length of stay, that goes from 5 days on average for a normal, uninfected patient, to 22 days if they’ve had an infection. The mortality rate can be as high as 6% in those people that have developed infections, so that in itself is an enormous burden.”

He went on to discuss the most common HAIs in the hospital setting and noted that combating them involves strategies that consider people, the environment, and technology. He predicted that in coming years clinicians will have a better “analytic capability to understand what we’ve done in the past and what correlates with success in the future, and then be able to implement and learn from that.”

Dr. Lobdell reported having no financial disclosures.

[email protected]

PHOENIX – If you happen to believe that the impact of health care–acquired infections is insignificant, think again. According to Dr. Kevin W. Lobdell, health care–acquired infections (HAIs) cause more deaths each year in the United States than breast cancer, lung cancer, and AIDS combined.

“If you look at hospitalized patients, one in five will acquire a health care–acquired infection,” Dr. Lobdell of the Sanger Heart and Vascular Institute at Carolinas Health System, Charlotte, N.C., said in a video interview at the annual meeting of the Society of Thoracic Surgeons. “With respect to length of stay, that goes from 5 days on average for a normal, uninfected patient, to 22 days if they’ve had an infection. The mortality rate can be as high as 6% in those people that have developed infections, so that in itself is an enormous burden.”

He went on to discuss the most common HAIs in the hospital setting and noted that combating them involves strategies that consider people, the environment, and technology. He predicted that in coming years clinicians will have a better “analytic capability to understand what we’ve done in the past and what correlates with success in the future, and then be able to implement and learn from that.”

Dr. Lobdell reported having no financial disclosures.

[email protected]

PHOENIX – If you happen to believe that the impact of health care–acquired infections is insignificant, think again. According to Dr. Kevin W. Lobdell, health care–acquired infections (HAIs) cause more deaths each year in the United States than breast cancer, lung cancer, and AIDS combined.

“If you look at hospitalized patients, one in five will acquire a health care–acquired infection,” Dr. Lobdell of the Sanger Heart and Vascular Institute at Carolinas Health System, Charlotte, N.C., said in a video interview at the annual meeting of the Society of Thoracic Surgeons. “With respect to length of stay, that goes from 5 days on average for a normal, uninfected patient, to 22 days if they’ve had an infection. The mortality rate can be as high as 6% in those people that have developed infections, so that in itself is an enormous burden.”

He went on to discuss the most common HAIs in the hospital setting and noted that combating them involves strategies that consider people, the environment, and technology. He predicted that in coming years clinicians will have a better “analytic capability to understand what we’ve done in the past and what correlates with success in the future, and then be able to implement and learn from that.”

Dr. Lobdell reported having no financial disclosures.

[email protected]

SAN ANTONIO – Four days of antibiotics is sufficient and safe for percutaneous drainage of complicated intra-abdominal infections in non-ICU patients, according to investigators from the University of Miami.

“There was no difference in outcome between a shorter and longer duration of antimicrobial therapy in those with percutaneously drained source control of a CIAI [complicated intra-abdominal infection]. Percutaneously drained intra-abdominal infections do not require longer duration of antimicrobial therapy,” they concluded.

The findings are from a posthoc subgroup analysis of the influential STOP-IT [Study to Optimize Peritoneal Infection Therapy] trial, which found that in CIAI patients with adequate source control, “the outcomes after fixed-duration antibiotic therapy (approximately 4 days) were similar to those after a longer course of antibiotics (approximately 7 days) that extended until after the resolution of physiological abnormalities” (N Engl J Med. 2015 May 21;372[21]:1996-2005).

STOP-IT lumped together patients who had both surgical and percutaneous source control. Unlike surgical clean out, percutaneous drainage usually leaves behind some infection; the Miami investigators wanted to see if that made a difference in the safety and effectiveness of short-course antibiotics. Seventy-two patients received a 4-day course and 57 were on antibiotics until 2 days after their symptoms resolved, which usually worked out to about 7 days.

There were no statistically significant differences between the groups in the rates of recurrent intra-abdominal infection (9.7% in the 4-day group vs. 10.5% in the longer-duration group, P = 1.00), Clostridium difficile infection (0% vs. 1.8%; P = .442), and hospital days (a mean of 4 days in both). The only difference was that the time to recurrent infection was shorter in the 4-day group (12.7 vs. 21.3 days; P = .015). None of the patients died.

The big caveat with STOP-IT and the posthoc analysis is that the patients weren’t very sick. Their mean APACHE [Acute Physiology and Chronic Health Evaluation] score was 10, and fevers and leukocytosis were generally mild. Patients without adequate source control, patients with open abdomens, and those likely to die within 72 hours were excluded.

“They were very different from our patients in the ICU with major complex intra-abdominal infections and septic shock and multiorgan dysfunction. To take STOP-IT or our analysis and say we are going to extrapolate that to our sickest patients and stop their antibiotics at 4 days is dangerous without further study. That’s the population everyone’s asking about now. We need a larger [randomized, controlled trial] in a much sicker population” to know how to handle the issue, said posthoc investigator Dr. Rishi Rattan, a critical care and trauma surgery fellow at the University of Miami.

The other big question, as raised by an audience member, and one at the other end of the spectrum is if antibiotics are needed at all after adequate source control, at least in some patients.

“We should look at that. I think we need to push the envelope and drill down even further to 48 and 24 hours, and study that versus 4 days,” Dr. Rattan said at the Eastern Association for the Surgery of Trauma scientific assembly.

Patients in STOP-IT were aged 16 years and older with either a temperature of at least 38º C, white blood cell counts of 11,000 cells/mm³ or higher, or peritonitis-induced gastrointestinal dysfunction. Baseline demographics, comorbidities, and illness severity were similar between treatment arms. Appendicitis was limited to about 10% of infections, so there was a diversity of infections and heterogeneity in the study population. Antibiotic selection was empiric, based on investigators’ institutions.

Based on STOP-IT, the University of Miami now usually limits antibiotics to 4 days after source control of CIAI in less-sick patients. The University was a STOP-IT site, which is why the posthoc team had access to the data.

The investigators have no disclosures.

[email protected]

SAN ANTONIO – Four days of antibiotics is sufficient and safe for percutaneous drainage of complicated intra-abdominal infections in non-ICU patients, according to investigators from the University of Miami.

“There was no difference in outcome between a shorter and longer duration of antimicrobial therapy in those with percutaneously drained source control of a CIAI [complicated intra-abdominal infection]. Percutaneously drained intra-abdominal infections do not require longer duration of antimicrobial therapy,” they concluded.

The findings are from a posthoc subgroup analysis of the influential STOP-IT [Study to Optimize Peritoneal Infection Therapy] trial, which found that in CIAI patients with adequate source control, “the outcomes after fixed-duration antibiotic therapy (approximately 4 days) were similar to those after a longer course of antibiotics (approximately 7 days) that extended until after the resolution of physiological abnormalities” (N Engl J Med. 2015 May 21;372[21]:1996-2005).

STOP-IT lumped together patients who had both surgical and percutaneous source control. Unlike surgical clean out, percutaneous drainage usually leaves behind some infection; the Miami investigators wanted to see if that made a difference in the safety and effectiveness of short-course antibiotics. Seventy-two patients received a 4-day course and 57 were on antibiotics until 2 days after their symptoms resolved, which usually worked out to about 7 days.

There were no statistically significant differences between the groups in the rates of recurrent intra-abdominal infection (9.7% in the 4-day group vs. 10.5% in the longer-duration group, P = 1.00), Clostridium difficile infection (0% vs. 1.8%; P = .442), and hospital days (a mean of 4 days in both). The only difference was that the time to recurrent infection was shorter in the 4-day group (12.7 vs. 21.3 days; P = .015). None of the patients died.

The big caveat with STOP-IT and the posthoc analysis is that the patients weren’t very sick. Their mean APACHE [Acute Physiology and Chronic Health Evaluation] score was 10, and fevers and leukocytosis were generally mild. Patients without adequate source control, patients with open abdomens, and those likely to die within 72 hours were excluded.

“They were very different from our patients in the ICU with major complex intra-abdominal infections and septic shock and multiorgan dysfunction. To take STOP-IT or our analysis and say we are going to extrapolate that to our sickest patients and stop their antibiotics at 4 days is dangerous without further study. That’s the population everyone’s asking about now. We need a larger [randomized, controlled trial] in a much sicker population” to know how to handle the issue, said posthoc investigator Dr. Rishi Rattan, a critical care and trauma surgery fellow at the University of Miami.

The other big question, as raised by an audience member, and one at the other end of the spectrum is if antibiotics are needed at all after adequate source control, at least in some patients.

“We should look at that. I think we need to push the envelope and drill down even further to 48 and 24 hours, and study that versus 4 days,” Dr. Rattan said at the Eastern Association for the Surgery of Trauma scientific assembly.

Patients in STOP-IT were aged 16 years and older with either a temperature of at least 38º C, white blood cell counts of 11,000 cells/mm³ or higher, or peritonitis-induced gastrointestinal dysfunction. Baseline demographics, comorbidities, and illness severity were similar between treatment arms. Appendicitis was limited to about 10% of infections, so there was a diversity of infections and heterogeneity in the study population. Antibiotic selection was empiric, based on investigators’ institutions.

Based on STOP-IT, the University of Miami now usually limits antibiotics to 4 days after source control of CIAI in less-sick patients. The University was a STOP-IT site, which is why the posthoc team had access to the data.

The investigators have no disclosures.

[email protected]

SAN ANTONIO – Four days of antibiotics is sufficient and safe for percutaneous drainage of complicated intra-abdominal infections in non-ICU patients, according to investigators from the University of Miami.

“There was no difference in outcome between a shorter and longer duration of antimicrobial therapy in those with percutaneously drained source control of a CIAI [complicated intra-abdominal infection]. Percutaneously drained intra-abdominal infections do not require longer duration of antimicrobial therapy,” they concluded.

The findings are from a posthoc subgroup analysis of the influential STOP-IT [Study to Optimize Peritoneal Infection Therapy] trial, which found that in CIAI patients with adequate source control, “the outcomes after fixed-duration antibiotic therapy (approximately 4 days) were similar to those after a longer course of antibiotics (approximately 7 days) that extended until after the resolution of physiological abnormalities” (N Engl J Med. 2015 May 21;372[21]:1996-2005).

STOP-IT lumped together patients who had both surgical and percutaneous source control. Unlike surgical clean out, percutaneous drainage usually leaves behind some infection; the Miami investigators wanted to see if that made a difference in the safety and effectiveness of short-course antibiotics. Seventy-two patients received a 4-day course and 57 were on antibiotics until 2 days after their symptoms resolved, which usually worked out to about 7 days.

There were no statistically significant differences between the groups in the rates of recurrent intra-abdominal infection (9.7% in the 4-day group vs. 10.5% in the longer-duration group, P = 1.00), Clostridium difficile infection (0% vs. 1.8%; P = .442), and hospital days (a mean of 4 days in both). The only difference was that the time to recurrent infection was shorter in the 4-day group (12.7 vs. 21.3 days; P = .015). None of the patients died.

The big caveat with STOP-IT and the posthoc analysis is that the patients weren’t very sick. Their mean APACHE [Acute Physiology and Chronic Health Evaluation] score was 10, and fevers and leukocytosis were generally mild. Patients without adequate source control, patients with open abdomens, and those likely to die within 72 hours were excluded.

“They were very different from our patients in the ICU with major complex intra-abdominal infections and septic shock and multiorgan dysfunction. To take STOP-IT or our analysis and say we are going to extrapolate that to our sickest patients and stop their antibiotics at 4 days is dangerous without further study. That’s the population everyone’s asking about now. We need a larger [randomized, controlled trial] in a much sicker population” to know how to handle the issue, said posthoc investigator Dr. Rishi Rattan, a critical care and trauma surgery fellow at the University of Miami.

The other big question, as raised by an audience member, and one at the other end of the spectrum is if antibiotics are needed at all after adequate source control, at least in some patients.

“We should look at that. I think we need to push the envelope and drill down even further to 48 and 24 hours, and study that versus 4 days,” Dr. Rattan said at the Eastern Association for the Surgery of Trauma scientific assembly.

Patients in STOP-IT were aged 16 years and older with either a temperature of at least 38º C, white blood cell counts of 11,000 cells/mm³ or higher, or peritonitis-induced gastrointestinal dysfunction. Baseline demographics, comorbidities, and illness severity were similar between treatment arms. Appendicitis was limited to about 10% of infections, so there was a diversity of infections and heterogeneity in the study population. Antibiotic selection was empiric, based on investigators’ institutions.

Based on STOP-IT, the University of Miami now usually limits antibiotics to 4 days after source control of CIAI in less-sick patients. The University was a STOP-IT site, which is why the posthoc team had access to the data.

The investigators have no disclosures.

[email protected]

Patient isolation in their own rooms is the most important factor in controlling outbreaks of norovirus within hospitals, according to a report in the Journal of Infectious Diseases.

Investigators surveyed six London hospitals for a 3-month period to gather data concerning norovirus outbreaks. They assessed two teaching hospitals with 230 and 780 beds, respectively; one specialist center with 160 beds; two district general hospitals with 284 and 650 beds, respectively; and one 100-bed community hospital. There were 20 norovirus outbreaks during the survey period involving 57 patients and 7 staff members, said Martina Cummins, a nurse consultant and deputy director, Infection Prevention and Control, Bart’s Health NHS Trust, Ilford (England) and Derren Ready, a clinical scientist at Public Health England, London.

©Aunt_Spray/Thinkstock

The number of outbreaks varied markedly among the different hospitals. The smaller teaching hospital and the smaller district general hospital had zero outbreaks, while the specialist hospital and the community hospital had only one outbreak each involving only three and six patients, respectively. The larger teaching hospital had two outbreaks involving only four patients in total. In contrast, the larger district general hospital, which had an older infrastructure, had 16 separate outbreaks involving 44 patients, and it was the only facility in which staff members (7) also became ill.

The ability to control an outbreak of norovirus hinged on the availability of isolation rooms. All the hospitals with two or fewer outbreaks had easily available isolation rooms, while the hospital that had numerous outbreaks did not. The most severely affected hospital had large wards caring for up to 26 patients, with limited or no barriers between beds. The beds in these wards were closer together (within 2.3 meters) than those in all the other hospitals. In addition, this hospital had limited care facilities, including only two sinks per ward for staff members to use and only four shared toilets per ward, Ms. Cummins and Mr. Ready said (J Infect Dis. 2016;213[S1]:S12-S14. doi:10.1093/infdis/jiv529).

Norovirus outbreaks among patients can have a major impact on the affected departments, wards, or clinical areas, but those that extend to staff members can lead to severe staffing shortages that close down whole wards or even entire hospitals, they noted.

No sponsor or funding source was identified for this study. Ms. Cummins and Mr. Ready reported having no relevant financial disclosures.

Patient isolation in their own rooms is the most important factor in controlling outbreaks of norovirus within hospitals, according to a report in the Journal of Infectious Diseases.

Investigators surveyed six London hospitals for a 3-month period to gather data concerning norovirus outbreaks. They assessed two teaching hospitals with 230 and 780 beds, respectively; one specialist center with 160 beds; two district general hospitals with 284 and 650 beds, respectively; and one 100-bed community hospital. There were 20 norovirus outbreaks during the survey period involving 57 patients and 7 staff members, said Martina Cummins, a nurse consultant and deputy director, Infection Prevention and Control, Bart’s Health NHS Trust, Ilford (England) and Derren Ready, a clinical scientist at Public Health England, London.

©Aunt_Spray/Thinkstock

The number of outbreaks varied markedly among the different hospitals. The smaller teaching hospital and the smaller district general hospital had zero outbreaks, while the specialist hospital and the community hospital had only one outbreak each involving only three and six patients, respectively. The larger teaching hospital had two outbreaks involving only four patients in total. In contrast, the larger district general hospital, which had an older infrastructure, had 16 separate outbreaks involving 44 patients, and it was the only facility in which staff members (7) also became ill.

The ability to control an outbreak of norovirus hinged on the availability of isolation rooms. All the hospitals with two or fewer outbreaks had easily available isolation rooms, while the hospital that had numerous outbreaks did not. The most severely affected hospital had large wards caring for up to 26 patients, with limited or no barriers between beds. The beds in these wards were closer together (within 2.3 meters) than those in all the other hospitals. In addition, this hospital had limited care facilities, including only two sinks per ward for staff members to use and only four shared toilets per ward, Ms. Cummins and Mr. Ready said (J Infect Dis. 2016;213[S1]:S12-S14. doi:10.1093/infdis/jiv529).

Norovirus outbreaks among patients can have a major impact on the affected departments, wards, or clinical areas, but those that extend to staff members can lead to severe staffing shortages that close down whole wards or even entire hospitals, they noted.

No sponsor or funding source was identified for this study. Ms. Cummins and Mr. Ready reported having no relevant financial disclosures.

Patient isolation in their own rooms is the most important factor in controlling outbreaks of norovirus within hospitals, according to a report in the Journal of Infectious Diseases.

Investigators surveyed six London hospitals for a 3-month period to gather data concerning norovirus outbreaks. They assessed two teaching hospitals with 230 and 780 beds, respectively; one specialist center with 160 beds; two district general hospitals with 284 and 650 beds, respectively; and one 100-bed community hospital. There were 20 norovirus outbreaks during the survey period involving 57 patients and 7 staff members, said Martina Cummins, a nurse consultant and deputy director, Infection Prevention and Control, Bart’s Health NHS Trust, Ilford (England) and Derren Ready, a clinical scientist at Public Health England, London.

©Aunt_Spray/Thinkstock

The number of outbreaks varied markedly among the different hospitals. The smaller teaching hospital and the smaller district general hospital had zero outbreaks, while the specialist hospital and the community hospital had only one outbreak each involving only three and six patients, respectively. The larger teaching hospital had two outbreaks involving only four patients in total. In contrast, the larger district general hospital, which had an older infrastructure, had 16 separate outbreaks involving 44 patients, and it was the only facility in which staff members (7) also became ill.

The ability to control an outbreak of norovirus hinged on the availability of isolation rooms. All the hospitals with two or fewer outbreaks had easily available isolation rooms, while the hospital that had numerous outbreaks did not. The most severely affected hospital had large wards caring for up to 26 patients, with limited or no barriers between beds. The beds in these wards were closer together (within 2.3 meters) than those in all the other hospitals. In addition, this hospital had limited care facilities, including only two sinks per ward for staff members to use and only four shared toilets per ward, Ms. Cummins and Mr. Ready said (J Infect Dis. 2016;213[S1]:S12-S14. doi:10.1093/infdis/jiv529).

Norovirus outbreaks among patients can have a major impact on the affected departments, wards, or clinical areas, but those that extend to staff members can lead to severe staffing shortages that close down whole wards or even entire hospitals, they noted.

No sponsor or funding source was identified for this study. Ms. Cummins and Mr. Ready reported having no relevant financial disclosures.

Fecal microbiota transplantation using frozen-then-thawed fecal material proved noninferior to that using fresh material for treating recurrent or refractory Clostridium difficile infection, according to a report published online Jan. 12 in JAMA.

Using frozen rather than fresh fecal material offers many advantages, such as allowing much more widespread and immediate accessibility of the treatment; reducing the number and frequency of donor screenings, which in turn would reduce costs; and ameliorating concern about potential transmission of pathogens from the donor to the recipient, since samples could be stored in quarantine until screening results are known, said Dr. Christine H. Lee of the department of pathology and molecular medicine, McMaster University, Hamilton (Ont.), and her associates.

CDC/D. Holdeman

They performed a 2-year randomized, double-blind noninferiority trial at six academic medical centers in Canada to compare frozen with fresh donor material in 232 adults with recurrent or refractory C. difficile infection. These study participants had “an extensive burden of comorbidity”: most had inflammatory bowel diseases and approximately 85% were immunocompromised, having undergone chronic hemodialysis or kidney transplantation, or having had metastatic solid tumors or hematologic malignancies. Half of the study subjects were inpatients, and approximately 75% were aged 65 years and older.

The patients were assigned to receive 50 mL of frozen-then-thawed FMT (114 participants) or fresh FMT (118 participants) by retention enema, delivered using 60-mL syringes. Those who didn’t improve by day 4 were given an additional FMT from the same donor. “Administration by enema is significantly less invasive than colonoscopy or nasojejunal/gastric administration and can be performed outside an acute care facility,” Dr. Lee and her associates noted.

The primary efficacy endpoint was clinical resolution, defined as no recurrence of C. difficile–related diarrhea at 13 weeks and no need for antibiotics. In the per-protocol population, 83.5% of the frozen FMT group and 85.1% of the fresh FMT group achieved this endpoint. In the intention-to-treat population, 75.0% of the frozen FMT group and 70.3% of the fresh FMT group achieved it. Both results demonstrate the noninferiority of frozen FMT, the investigators said (JAMA. 2016;315[2]:142-9. doi:10.1001/jama.201518098).

The proportion of adverse events and severe adverse events was deemed low and did not differ between the two study groups. The most common adverse events that may possibly have been related to treatment occurred in similar numbers of each group and included transient diarrhea, abdominal cramps, and nausea during the first 24 hours after transplantation and constipation and excess flatulence during the 13-week follow-up.

Even though this follow-up was longer than that in most clinical trials of FMT for C. difficile infection, which only tracked patients for 40 days, it is still insufficient to assess the long-term safety of the treatment. Ten-year follow-up of the participants in this trial is currently under way to examine any beneficial effects the treatment might exert on the metabolic syndrome, diabetes, or autoimmune disease, as well as any negative effects such as the development of autoimmune disorders or cancer.

Fecal microbiota transplantation using frozen-then-thawed fecal material proved noninferior to that using fresh material for treating recurrent or refractory Clostridium difficile infection, according to a report published online Jan. 12 in JAMA.

Using frozen rather than fresh fecal material offers many advantages, such as allowing much more widespread and immediate accessibility of the treatment; reducing the number and frequency of donor screenings, which in turn would reduce costs; and ameliorating concern about potential transmission of pathogens from the donor to the recipient, since samples could be stored in quarantine until screening results are known, said Dr. Christine H. Lee of the department of pathology and molecular medicine, McMaster University, Hamilton (Ont.), and her associates.

CDC/D. Holdeman

They performed a 2-year randomized, double-blind noninferiority trial at six academic medical centers in Canada to compare frozen with fresh donor material in 232 adults with recurrent or refractory C. difficile infection. These study participants had “an extensive burden of comorbidity”: most had inflammatory bowel diseases and approximately 85% were immunocompromised, having undergone chronic hemodialysis or kidney transplantation, or having had metastatic solid tumors or hematologic malignancies. Half of the study subjects were inpatients, and approximately 75% were aged 65 years and older.

The patients were assigned to receive 50 mL of frozen-then-thawed FMT (114 participants) or fresh FMT (118 participants) by retention enema, delivered using 60-mL syringes. Those who didn’t improve by day 4 were given an additional FMT from the same donor. “Administration by enema is significantly less invasive than colonoscopy or nasojejunal/gastric administration and can be performed outside an acute care facility,” Dr. Lee and her associates noted.

The primary efficacy endpoint was clinical resolution, defined as no recurrence of C. difficile–related diarrhea at 13 weeks and no need for antibiotics. In the per-protocol population, 83.5% of the frozen FMT group and 85.1% of the fresh FMT group achieved this endpoint. In the intention-to-treat population, 75.0% of the frozen FMT group and 70.3% of the fresh FMT group achieved it. Both results demonstrate the noninferiority of frozen FMT, the investigators said (JAMA. 2016;315[2]:142-9. doi:10.1001/jama.201518098).

The proportion of adverse events and severe adverse events was deemed low and did not differ between the two study groups. The most common adverse events that may possibly have been related to treatment occurred in similar numbers of each group and included transient diarrhea, abdominal cramps, and nausea during the first 24 hours after transplantation and constipation and excess flatulence during the 13-week follow-up.

Even though this follow-up was longer than that in most clinical trials of FMT for C. difficile infection, which only tracked patients for 40 days, it is still insufficient to assess the long-term safety of the treatment. Ten-year follow-up of the participants in this trial is currently under way to examine any beneficial effects the treatment might exert on the metabolic syndrome, diabetes, or autoimmune disease, as well as any negative effects such as the development of autoimmune disorders or cancer.

Fecal microbiota transplantation using frozen-then-thawed fecal material proved noninferior to that using fresh material for treating recurrent or refractory Clostridium difficile infection, according to a report published online Jan. 12 in JAMA.

Using frozen rather than fresh fecal material offers many advantages, such as allowing much more widespread and immediate accessibility of the treatment; reducing the number and frequency of donor screenings, which in turn would reduce costs; and ameliorating concern about potential transmission of pathogens from the donor to the recipient, since samples could be stored in quarantine until screening results are known, said Dr. Christine H. Lee of the department of pathology and molecular medicine, McMaster University, Hamilton (Ont.), and her associates.

CDC/D. Holdeman

They performed a 2-year randomized, double-blind noninferiority trial at six academic medical centers in Canada to compare frozen with fresh donor material in 232 adults with recurrent or refractory C. difficile infection. These study participants had “an extensive burden of comorbidity”: most had inflammatory bowel diseases and approximately 85% were immunocompromised, having undergone chronic hemodialysis or kidney transplantation, or having had metastatic solid tumors or hematologic malignancies. Half of the study subjects were inpatients, and approximately 75% were aged 65 years and older.

The patients were assigned to receive 50 mL of frozen-then-thawed FMT (114 participants) or fresh FMT (118 participants) by retention enema, delivered using 60-mL syringes. Those who didn’t improve by day 4 were given an additional FMT from the same donor. “Administration by enema is significantly less invasive than colonoscopy or nasojejunal/gastric administration and can be performed outside an acute care facility,” Dr. Lee and her associates noted.

The primary efficacy endpoint was clinical resolution, defined as no recurrence of C. difficile–related diarrhea at 13 weeks and no need for antibiotics. In the per-protocol population, 83.5% of the frozen FMT group and 85.1% of the fresh FMT group achieved this endpoint. In the intention-to-treat population, 75.0% of the frozen FMT group and 70.3% of the fresh FMT group achieved it. Both results demonstrate the noninferiority of frozen FMT, the investigators said (JAMA. 2016;315[2]:142-9. doi:10.1001/jama.201518098).

The proportion of adverse events and severe adverse events was deemed low and did not differ between the two study groups. The most common adverse events that may possibly have been related to treatment occurred in similar numbers of each group and included transient diarrhea, abdominal cramps, and nausea during the first 24 hours after transplantation and constipation and excess flatulence during the 13-week follow-up.

Even though this follow-up was longer than that in most clinical trials of FMT for C. difficile infection, which only tracked patients for 40 days, it is still insufficient to assess the long-term safety of the treatment. Ten-year follow-up of the participants in this trial is currently under way to examine any beneficial effects the treatment might exert on the metabolic syndrome, diabetes, or autoimmune disease, as well as any negative effects such as the development of autoimmune disorders or cancer.

Uninsured patients can be trained to safely and efficiently self-administer long-term intravenous antibiotics, according to a 4-year outcomes study published in PLOS Medicine.

Between 2010 and 2013, 994 uninsured patients at Parkland Hospital in Dallas were enrolled in a self-administered outpatient parenteral antimicrobial therapy (S-OPAT) program, and 224 insured patients were discharged to a health care–administered OPAT program. Patients in the S-OPAT group were trained to self-administer intravenous antimicrobials, tested for their ability to treat themselves before discharge, and then monitored by weekly visits to the S-OPAT outpatient clinic. The 224 insured patients in the H-OPAT program had antibiotics administered by a health care worker.

©Bhakpong/thinkstockphotos.com

A research team led by Dr. Kavita Bhavan of University of Texas Southwestern Medical Center, Dallas, estimated the effect of S-OPAT versus H-OPAT on 30-day all-cause readmission and 1-year all-cause mortality after controlling for selection bias with a propensity score developed using baseline clinical and sociodemographic information collected from the patients.

The 30-day readmission rate was 47% lower in the S-OPAT group than in the H-OPAT group, and the 1-year mortality rate did not differ significantly between the two groups. Because the S-OPAT program resulted in patients spending fewer days having inpatient infusions, 27,666 inpatient days were avoided over the study period.

Thus, S-OPAT was associated with similar or better outcomes than H-OPAT, meaning S-OPAT may be an acceptable model of treatment for uninsured, medically stable patients to complete extended courses of intravenous antimicrobials at home.

Read the full study online at PLOS Medicine (PLoS Med. 2015 Dec 15;12[12]. doi: 10.1371/journal.pmed.1001922).

[email protected]

On Twitter @richpizzi

Uninsured patients can be trained to safely and efficiently self-administer long-term intravenous antibiotics, according to a 4-year outcomes study published in PLOS Medicine.

Between 2010 and 2013, 994 uninsured patients at Parkland Hospital in Dallas were enrolled in a self-administered outpatient parenteral antimicrobial therapy (S-OPAT) program, and 224 insured patients were discharged to a health care–administered OPAT program. Patients in the S-OPAT group were trained to self-administer intravenous antimicrobials, tested for their ability to treat themselves before discharge, and then monitored by weekly visits to the S-OPAT outpatient clinic. The 224 insured patients in the H-OPAT program had antibiotics administered by a health care worker.

©Bhakpong/thinkstockphotos.com

A research team led by Dr. Kavita Bhavan of University of Texas Southwestern Medical Center, Dallas, estimated the effect of S-OPAT versus H-OPAT on 30-day all-cause readmission and 1-year all-cause mortality after controlling for selection bias with a propensity score developed using baseline clinical and sociodemographic information collected from the patients.

The 30-day readmission rate was 47% lower in the S-OPAT group than in the H-OPAT group, and the 1-year mortality rate did not differ significantly between the two groups. Because the S-OPAT program resulted in patients spending fewer days having inpatient infusions, 27,666 inpatient days were avoided over the study period.

Thus, S-OPAT was associated with similar or better outcomes than H-OPAT, meaning S-OPAT may be an acceptable model of treatment for uninsured, medically stable patients to complete extended courses of intravenous antimicrobials at home.

Read the full study online at PLOS Medicine (PLoS Med. 2015 Dec 15;12[12]. doi: 10.1371/journal.pmed.1001922).

[email protected]

On Twitter @richpizzi

Uninsured patients can be trained to safely and efficiently self-administer long-term intravenous antibiotics, according to a 4-year outcomes study published in PLOS Medicine.

Between 2010 and 2013, 994 uninsured patients at Parkland Hospital in Dallas were enrolled in a self-administered outpatient parenteral antimicrobial therapy (S-OPAT) program, and 224 insured patients were discharged to a health care–administered OPAT program. Patients in the S-OPAT group were trained to self-administer intravenous antimicrobials, tested for their ability to treat themselves before discharge, and then monitored by weekly visits to the S-OPAT outpatient clinic. The 224 insured patients in the H-OPAT program had antibiotics administered by a health care worker.

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A research team led by Dr. Kavita Bhavan of University of Texas Southwestern Medical Center, Dallas, estimated the effect of S-OPAT versus H-OPAT on 30-day all-cause readmission and 1-year all-cause mortality after controlling for selection bias with a propensity score developed using baseline clinical and sociodemographic information collected from the patients.

The 30-day readmission rate was 47% lower in the S-OPAT group than in the H-OPAT group, and the 1-year mortality rate did not differ significantly between the two groups. Because the S-OPAT program resulted in patients spending fewer days having inpatient infusions, 27,666 inpatient days were avoided over the study period.

Thus, S-OPAT was associated with similar or better outcomes than H-OPAT, meaning S-OPAT may be an acceptable model of treatment for uninsured, medically stable patients to complete extended courses of intravenous antimicrobials at home.

Read the full study online at PLOS Medicine (PLoS Med. 2015 Dec 15;12[12]. doi: 10.1371/journal.pmed.1001922).

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On Twitter @richpizzi

ORLANDO – You can confidently treat mild to severe Clostridium difficile infection in persons with inflammatory bowel disease, without disrupting their immunosuppression or other treatments, according to an expert.

“If your patient with IBD needs a fecal transplant for C. diff., you should not be concerned about withholding it,” Dr. Alan C. Moss said during a basic science presentation at a conference on inflammatory bowel diseases (IBD), sponsored by the Crohn’s and Colitis Foundation of America. Dr. Moss is an associate professor of medicine and the director of translational research at Harvard Medical School, Boston.

The first step, after you’ve determined that your patient has a true C. diff. infection, as opposed to having only been colonized by the bacteria, is choosing the best antibiotic. “Unfortunately, almost all IBD patients are excluded from controlled trials of antibiotics in C. diff. infection, so all we really have to go on are retrospective cohort data,” said Dr. Moss.

One such study, uncontrolled for disease severity, showed that a third of 114 inpatients with IBD who had a co-occurring C. diff. infection had higher 30-day readmission rates when treated first with metronidazole, per current standards of care, compared with the remaining two-thirds of patients who were treated first with vancomycin. The metronidazole group also averaged double the length of stays of the vancomycin group (Antimicrob Agents Chemother. 2014 Sep;58:5054-9 [doi: 10.1128/AAC.02606-13]).

“This suggests that in IBD patients, especially for those who meet criteria for a severe C. diff. infection, vancomycin is the way to go,” Dr. Moss said, noting a trend of metronidazole for mild infections in this cohort having ever less efficacy.

Beyond mild infection, Dr. Moss said the first line of treatment should be vancomycin 125 mg four times daily, or 500 mg four times daily if it is complicated disease.

If your patient has recurrent C. diff. infection, Dr. Moss recommended a prolonged taper of vancomycin, but to be vigilant about it being truly an infection and not a flare-up of colonized bacteria.

“My bar for doing fecal transplant in these patients has dropped considerably in the last few years, because if you really want to squeeze out the niche that C. diff. occupies in the microbiome, fecal transplant is really the most effective way we have of doing that,” Dr. Moss said.

While there is a division in the field over whether to continue immunosuppression during antibiotic treatment, Dr. Moss cited a small study indicating that if a patient were on two or more immunosuppressants, they had a higher risk of death, megacolon, or shock during C. diff. treatment. “I think it’s hard to draw many conclusions from that,” Dr. Moss said. “It may just be a surrogate marker of severity of disease rather than infection, per se.”

The standard of care for recurrent and refractory C. diff. infection is now fecal transplant, according to Dr. Moss. A recent study of fecal transplantation showed an 89% cure rate of C. diff. infection after a single fecal transplant in IBD patients. Of the 36 IBD patients in the study, half of whom were on biologic and immunosuppressive therapies, four experienced disease flare-ups (Am J Gastroenterol. 2014 Jul;109:1065-71 [doi: 10.1038/ajg.2014.133]. N Engl J Med. 2013 Jan 31;368:474-5 [doi: 10.1056/NEJMe1214816]).

As for determining if there is an actual infection rather than colonization of C. diff., Dr. Moss said switching from using ELISA (enzyme-linked immunoassay) testing to PCR (polymerase chain reaction) testing instead was helpful in first-time infections because the latter is more sensitive for determining actual infection; however, if a patient has recurrent infection, the higher clinical specificity of PCR makes it harder to tell if a positive result is infection or simply colonization.

Some institutions have dropped ELISA testing altogether, Dr. Moss said, although he thinks the use of single molecule array testing is, with its exponential sensitivity, a “good half-way step” between ELISA and PCR, and is useful for determining who is colonized vs. who is actually producing the toxin, even at a very low level.

Dr. Moss disclosed he has consulted for Janssen, Theravance, and Seres, and has received research support from the National Institute for Diabetes, Digestive, and Kidney Disease, and Helmsley.

[email protected]

On Twitter @whitneymcknight

ORLANDO – You can confidently treat mild to severe Clostridium difficile infection in persons with inflammatory bowel disease, without disrupting their immunosuppression or other treatments, according to an expert.

“If your patient with IBD needs a fecal transplant for C. diff., you should not be concerned about withholding it,” Dr. Alan C. Moss said during a basic science presentation at a conference on inflammatory bowel diseases (IBD), sponsored by the Crohn’s and Colitis Foundation of America. Dr. Moss is an associate professor of medicine and the director of translational research at Harvard Medical School, Boston.

The first step, after you’ve determined that your patient has a true C. diff. infection, as opposed to having only been colonized by the bacteria, is choosing the best antibiotic. “Unfortunately, almost all IBD patients are excluded from controlled trials of antibiotics in C. diff. infection, so all we really have to go on are retrospective cohort data,” said Dr. Moss.

One such study, uncontrolled for disease severity, showed that a third of 114 inpatients with IBD who had a co-occurring C. diff. infection had higher 30-day readmission rates when treated first with metronidazole, per current standards of care, compared with the remaining two-thirds of patients who were treated first with vancomycin. The metronidazole group also averaged double the length of stays of the vancomycin group (Antimicrob Agents Chemother. 2014 Sep;58:5054-9 [doi: 10.1128/AAC.02606-13]).

“This suggests that in IBD patients, especially for those who meet criteria for a severe C. diff. infection, vancomycin is the way to go,” Dr. Moss said, noting a trend of metronidazole for mild infections in this cohort having ever less efficacy.

Beyond mild infection, Dr. Moss said the first line of treatment should be vancomycin 125 mg four times daily, or 500 mg four times daily if it is complicated disease.

If your patient has recurrent C. diff. infection, Dr. Moss recommended a prolonged taper of vancomycin, but to be vigilant about it being truly an infection and not a flare-up of colonized bacteria.

“My bar for doing fecal transplant in these patients has dropped considerably in the last few years, because if you really want to squeeze out the niche that C. diff. occupies in the microbiome, fecal transplant is really the most effective way we have of doing that,” Dr. Moss said.

While there is a division in the field over whether to continue immunosuppression during antibiotic treatment, Dr. Moss cited a small study indicating that if a patient were on two or more immunosuppressants, they had a higher risk of death, megacolon, or shock during C. diff. treatment. “I think it’s hard to draw many conclusions from that,” Dr. Moss said. “It may just be a surrogate marker of severity of disease rather than infection, per se.”

The standard of care for recurrent and refractory C. diff. infection is now fecal transplant, according to Dr. Moss. A recent study of fecal transplantation showed an 89% cure rate of C. diff. infection after a single fecal transplant in IBD patients. Of the 36 IBD patients in the study, half of whom were on biologic and immunosuppressive therapies, four experienced disease flare-ups (Am J Gastroenterol. 2014 Jul;109:1065-71 [doi: 10.1038/ajg.2014.133]. N Engl J Med. 2013 Jan 31;368:474-5 [doi: 10.1056/NEJMe1214816]).

As for determining if there is an actual infection rather than colonization of C. diff., Dr. Moss said switching from using ELISA (enzyme-linked immunoassay) testing to PCR (polymerase chain reaction) testing instead was helpful in first-time infections because the latter is more sensitive for determining actual infection; however, if a patient has recurrent infection, the higher clinical specificity of PCR makes it harder to tell if a positive result is infection or simply colonization.

Some institutions have dropped ELISA testing altogether, Dr. Moss said, although he thinks the use of single molecule array testing is, with its exponential sensitivity, a “good half-way step” between ELISA and PCR, and is useful for determining who is colonized vs. who is actually producing the toxin, even at a very low level.

Dr. Moss disclosed he has consulted for Janssen, Theravance, and Seres, and has received research support from the National Institute for Diabetes, Digestive, and Kidney Disease, and Helmsley.

[email protected]

On Twitter @whitneymcknight

ORLANDO – You can confidently treat mild to severe Clostridium difficile infection in persons with inflammatory bowel disease, without disrupting their immunosuppression or other treatments, according to an expert.

“If your patient with IBD needs a fecal transplant for C. diff., you should not be concerned about withholding it,” Dr. Alan C. Moss said during a basic science presentation at a conference on inflammatory bowel diseases (IBD), sponsored by the Crohn’s and Colitis Foundation of America. Dr. Moss is an associate professor of medicine and the director of translational research at Harvard Medical School, Boston.

The first step, after you’ve determined that your patient has a true C. diff. infection, as opposed to having only been colonized by the bacteria, is choosing the best antibiotic. “Unfortunately, almost all IBD patients are excluded from controlled trials of antibiotics in C. diff. infection, so all we really have to go on are retrospective cohort data,” said Dr. Moss.

One such study, uncontrolled for disease severity, showed that a third of 114 inpatients with IBD who had a co-occurring C. diff. infection had higher 30-day readmission rates when treated first with metronidazole, per current standards of care, compared with the remaining two-thirds of patients who were treated first with vancomycin. The metronidazole group also averaged double the length of stays of the vancomycin group (Antimicrob Agents Chemother. 2014 Sep;58:5054-9 [doi: 10.1128/AAC.02606-13]).

“This suggests that in IBD patients, especially for those who meet criteria for a severe C. diff. infection, vancomycin is the way to go,” Dr. Moss said, noting a trend of metronidazole for mild infections in this cohort having ever less efficacy.

Beyond mild infection, Dr. Moss said the first line of treatment should be vancomycin 125 mg four times daily, or 500 mg four times daily if it is complicated disease.

If your patient has recurrent C. diff. infection, Dr. Moss recommended a prolonged taper of vancomycin, but to be vigilant about it being truly an infection and not a flare-up of colonized bacteria.

“My bar for doing fecal transplant in these patients has dropped considerably in the last few years, because if you really want to squeeze out the niche that C. diff. occupies in the microbiome, fecal transplant is really the most effective way we have of doing that,” Dr. Moss said.

While there is a division in the field over whether to continue immunosuppression during antibiotic treatment, Dr. Moss cited a small study indicating that if a patient were on two or more immunosuppressants, they had a higher risk of death, megacolon, or shock during C. diff. treatment. “I think it’s hard to draw many conclusions from that,” Dr. Moss said. “It may just be a surrogate marker of severity of disease rather than infection, per se.”

The standard of care for recurrent and refractory C. diff. infection is now fecal transplant, according to Dr. Moss. A recent study of fecal transplantation showed an 89% cure rate of C. diff. infection after a single fecal transplant in IBD patients. Of the 36 IBD patients in the study, half of whom were on biologic and immunosuppressive therapies, four experienced disease flare-ups (Am J Gastroenterol. 2014 Jul;109:1065-71 [doi: 10.1038/ajg.2014.133]. N Engl J Med. 2013 Jan 31;368:474-5 [doi: 10.1056/NEJMe1214816]).

As for determining if there is an actual infection rather than colonization of C. diff., Dr. Moss said switching from using ELISA (enzyme-linked immunoassay) testing to PCR (polymerase chain reaction) testing instead was helpful in first-time infections because the latter is more sensitive for determining actual infection; however, if a patient has recurrent infection, the higher clinical specificity of PCR makes it harder to tell if a positive result is infection or simply colonization.

Some institutions have dropped ELISA testing altogether, Dr. Moss said, although he thinks the use of single molecule array testing is, with its exponential sensitivity, a “good half-way step” between ELISA and PCR, and is useful for determining who is colonized vs. who is actually producing the toxin, even at a very low level.

Dr. Moss disclosed he has consulted for Janssen, Theravance, and Seres, and has received research support from the National Institute for Diabetes, Digestive, and Kidney Disease, and Helmsley.

[email protected]

On Twitter @whitneymcknight

Hospitals and health centers that participate in orchestrated testing protocols for diagnosis and treatment of central line–associated bloodstream infections (CLABSI) have lower rates of hospital admissions, according to a new study published in Pediatrics.

“The purpose of the SLUG Bug (Standardizing Line Care Under Guideline Recommendations) collaborative was to provide potentially better practice recommendations for neonatal health care professionals in care and maintenance of CVCs [central venous catheters] and to prevent CLABSI [central line–associated bloodstream infections],” wrote Dr. Anthony J. Piazza of the department of pediatrics at Emory University, Atlanta, and his colleagues.

The researchers examined 17 health care centers, from which eight test groups were identified and evaluated via orchestrated testing methods. Each center was surveyed to compare CLABSI rates before and after implementation of SLUG Bug protocols, and to determine each center’s compliance rate on procedural aspects such as tubing change, hub care, and sterilization. The measurable target Dr. Piazza and his colleagues had in mind was to lower CLABSI rates by 15% – deemed “a clinically meaningful target” – over the course of 12 months (Pediatrics. 2016 Dec. 22. doi:10.1542/peds.2014-3642).

The mean CLABSI rate across centers declined from 1.333 per 1,000 line-days at baseline to 1.076 per 1,000 line-days at 12 months, a reduction of 19.28%, meeting the benchmark set by the investigators. Furthermore, all but 1 of the 17 centers included in the study recorded a compliance rate of 75% or higher. Of the eight study groups, only two did not see a reduction in CLABSI rates, with changes of 0.512 and 0.444; all other groups saw CLABSI rates decrease anywhere from –0.157 to –1.860.

“The CLABSI Clinical Practice Recommendation is generalizable to other settings in which prolonged CVC use is medically necessary,” the authors wrote, adding that the “results support strong consideration for the use of sterile [tubing change] in conjunction with [hub care] compliance monitoring to further reduce NICU rates of CLABSI.”

The study did not receive any outside funding. Dr. Piazza did not report any relevant financial disclosures, but several coauthors reported potential conflicts of their own.

[email protected]

Hospitals and health centers that participate in orchestrated testing protocols for diagnosis and treatment of central line–associated bloodstream infections (CLABSI) have lower rates of hospital admissions, according to a new study published in Pediatrics.

“The purpose of the SLUG Bug (Standardizing Line Care Under Guideline Recommendations) collaborative was to provide potentially better practice recommendations for neonatal health care professionals in care and maintenance of CVCs [central venous catheters] and to prevent CLABSI [central line–associated bloodstream infections],” wrote Dr. Anthony J. Piazza of the department of pediatrics at Emory University, Atlanta, and his colleagues.

The researchers examined 17 health care centers, from which eight test groups were identified and evaluated via orchestrated testing methods. Each center was surveyed to compare CLABSI rates before and after implementation of SLUG Bug protocols, and to determine each center’s compliance rate on procedural aspects such as tubing change, hub care, and sterilization. The measurable target Dr. Piazza and his colleagues had in mind was to lower CLABSI rates by 15% – deemed “a clinically meaningful target” – over the course of 12 months (Pediatrics. 2016 Dec. 22. doi:10.1542/peds.2014-3642).

The mean CLABSI rate across centers declined from 1.333 per 1,000 line-days at baseline to 1.076 per 1,000 line-days at 12 months, a reduction of 19.28%, meeting the benchmark set by the investigators. Furthermore, all but 1 of the 17 centers included in the study recorded a compliance rate of 75% or higher. Of the eight study groups, only two did not see a reduction in CLABSI rates, with changes of 0.512 and 0.444; all other groups saw CLABSI rates decrease anywhere from –0.157 to –1.860.

“The CLABSI Clinical Practice Recommendation is generalizable to other settings in which prolonged CVC use is medically necessary,” the authors wrote, adding that the “results support strong consideration for the use of sterile [tubing change] in conjunction with [hub care] compliance monitoring to further reduce NICU rates of CLABSI.”

The study did not receive any outside funding. Dr. Piazza did not report any relevant financial disclosures, but several coauthors reported potential conflicts of their own.

[email protected]

Hospitals and health centers that participate in orchestrated testing protocols for diagnosis and treatment of central line–associated bloodstream infections (CLABSI) have lower rates of hospital admissions, according to a new study published in Pediatrics.

“The purpose of the SLUG Bug (Standardizing Line Care Under Guideline Recommendations) collaborative was to provide potentially better practice recommendations for neonatal health care professionals in care and maintenance of CVCs [central venous catheters] and to prevent CLABSI [central line–associated bloodstream infections],” wrote Dr. Anthony J. Piazza of the department of pediatrics at Emory University, Atlanta, and his colleagues.

The researchers examined 17 health care centers, from which eight test groups were identified and evaluated via orchestrated testing methods. Each center was surveyed to compare CLABSI rates before and after implementation of SLUG Bug protocols, and to determine each center’s compliance rate on procedural aspects such as tubing change, hub care, and sterilization. The measurable target Dr. Piazza and his colleagues had in mind was to lower CLABSI rates by 15% – deemed “a clinically meaningful target” – over the course of 12 months (Pediatrics. 2016 Dec. 22. doi:10.1542/peds.2014-3642).

The mean CLABSI rate across centers declined from 1.333 per 1,000 line-days at baseline to 1.076 per 1,000 line-days at 12 months, a reduction of 19.28%, meeting the benchmark set by the investigators. Furthermore, all but 1 of the 17 centers included in the study recorded a compliance rate of 75% or higher. Of the eight study groups, only two did not see a reduction in CLABSI rates, with changes of 0.512 and 0.444; all other groups saw CLABSI rates decrease anywhere from –0.157 to –1.860.

“The CLABSI Clinical Practice Recommendation is generalizable to other settings in which prolonged CVC use is medically necessary,” the authors wrote, adding that the “results support strong consideration for the use of sterile [tubing change] in conjunction with [hub care] compliance monitoring to further reduce NICU rates of CLABSI.”

The study did not receive any outside funding. Dr. Piazza did not report any relevant financial disclosures, but several coauthors reported potential conflicts of their own.

[email protected]