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MADRID – An attempt to balance effective treatment with good antibiotic stewardship fell short when patients with cellulitis who got 6 days of flucloxacillin relapsed significantly sooner and more frequently than did those who received the standard 12 days of treatment.
While cellulitis cure rates at 14 and 28 days were similar between the two groups, 90-day relapse rates were significantly higher for those who took the 6-day course (23.5% vs. 6%), Duncan R. Cranendonk, MD, said at the European Congress of Clinical Microbiology and Infectious Diseases annual conference. The cohort demographics perhaps played into this finding: Most of the group was elderly, hospitalized, and had comorbid conditions.
“However, this is the population clinicians are most likely to see,” said Dr Cranendonk of the University of Amsterdam. “It appears that therapy cannot be safely shortened in this population.”
In light of recent antibiotic trials showing that shorter courses can be as effective as prolonged treatment, Dr. Cranendonk and his colleagues conducted the DANCE (Duration of Antibiotic Therapy for Cellulitis) trial. The study investigated the efficacy of an abbreviated course of intravenous flucloxacillin among 248 patients with cellulitis admitted to 11 Dutch hospitals. At treatment day 6, those who had clinically improved after their initial treatment were randomized to 6 additional days of IV flucloxacillin or to placebo. The primary outcome was cure by day 14 without relapse by day 28.
A 2004 study successfully paved the way for DANCE, Dr. Cranendonk noted. That trial examined 5 versus 10 days of levofloxacin 500 mg for uncomplicated cellulitis in 87 patients. The outcome was positive: There was no significant difference in clinical outcome between the two arms, with a 98% cure rate in both groups.
However, Dr. Cranendonk noted, there were some important differences between the patients in that study and the DANCE cohort. They were, on the whole, younger and generally in better overall health. Also, only 15% of those patients were hospitalized for their infections, while all of the DANCE subjects were treated in the hospital.
Patients enrolled in DANCE were a mean of 62 years old, with a median 28 kg/m2 body mass index. About 40% had experienced cellulitis before, and 25% had diabetes. Most infections were on the leg (84%) and involved the lower leg or the lower leg and the foot. Fever was present in half of the group, lymphadenopathy in a third, and leukocytosis in 70%.
Upon enrollment, all 248 patients received 6 days of 1,000 mg/day IV flucloxacillin, with the option of a step-down to oral treatment (500 mg four times per day) at the treating physician’s discretion. At day 6, patients who were clinically improved (afebrile, no need to an antibiotic switch, no growth in blood culture, and improved symptoms of pain, ulceration, discharge, and fluctuance) were randomized to either another 6 days of flucloxacillin or placebo.
The primary endpoint was cure by day 14, with no relapse and no need for new antibiotics by day 28. The secondary endpoint was relapse by 90 days after initial cure.
After initial treatment, 151 patients entered the randomization phase. At 28 days, relapse-free cure rates were nearly identical: 49% of the 12-day group and 50% of the 6-day group. However, by 90 days, a significant difference became apparent: Patients who had received the 6-day course of flucloxacillin were significantly more likely to have experienced a relapse of cellulitis in the same region (23.5% vs. 6% in the 12-day group). A Kaplan-Meier analysis showed that these patients began to relapse as early as 35 days after the end of therapy. Most relapses occurred during days 60-90. The few relapses in the 12-day group occurred toward the end of the follow-up period, from day 75 onward.
Dr. Cranendonk said the investigation shows that older, less-healthy cellulitis patients can probably benefit from the longer course of antibiotics. “Short-term outcomes aren’t everything,” he noted.
He had no financial disclosures.
A video interview of Dr. Cranendock by ECCMID 2018 is available.
SOURCE: Cranendonk et al. ECCMID 2018, Abstract O1122
MADRID – An attempt to balance effective treatment with good antibiotic stewardship fell short when patients with cellulitis who got 6 days of flucloxacillin relapsed significantly sooner and more frequently than did those who received the standard 12 days of treatment.
While cellulitis cure rates at 14 and 28 days were similar between the two groups, 90-day relapse rates were significantly higher for those who took the 6-day course (23.5% vs. 6%), Duncan R. Cranendonk, MD, said at the European Congress of Clinical Microbiology and Infectious Diseases annual conference. The cohort demographics perhaps played into this finding: Most of the group was elderly, hospitalized, and had comorbid conditions.
“However, this is the population clinicians are most likely to see,” said Dr Cranendonk of the University of Amsterdam. “It appears that therapy cannot be safely shortened in this population.”
In light of recent antibiotic trials showing that shorter courses can be as effective as prolonged treatment, Dr. Cranendonk and his colleagues conducted the DANCE (Duration of Antibiotic Therapy for Cellulitis) trial. The study investigated the efficacy of an abbreviated course of intravenous flucloxacillin among 248 patients with cellulitis admitted to 11 Dutch hospitals. At treatment day 6, those who had clinically improved after their initial treatment were randomized to 6 additional days of IV flucloxacillin or to placebo. The primary outcome was cure by day 14 without relapse by day 28.
A 2004 study successfully paved the way for DANCE, Dr. Cranendonk noted. That trial examined 5 versus 10 days of levofloxacin 500 mg for uncomplicated cellulitis in 87 patients. The outcome was positive: There was no significant difference in clinical outcome between the two arms, with a 98% cure rate in both groups.
However, Dr. Cranendonk noted, there were some important differences between the patients in that study and the DANCE cohort. They were, on the whole, younger and generally in better overall health. Also, only 15% of those patients were hospitalized for their infections, while all of the DANCE subjects were treated in the hospital.
Patients enrolled in DANCE were a mean of 62 years old, with a median 28 kg/m2 body mass index. About 40% had experienced cellulitis before, and 25% had diabetes. Most infections were on the leg (84%) and involved the lower leg or the lower leg and the foot. Fever was present in half of the group, lymphadenopathy in a third, and leukocytosis in 70%.
Upon enrollment, all 248 patients received 6 days of 1,000 mg/day IV flucloxacillin, with the option of a step-down to oral treatment (500 mg four times per day) at the treating physician’s discretion. At day 6, patients who were clinically improved (afebrile, no need to an antibiotic switch, no growth in blood culture, and improved symptoms of pain, ulceration, discharge, and fluctuance) were randomized to either another 6 days of flucloxacillin or placebo.
The primary endpoint was cure by day 14, with no relapse and no need for new antibiotics by day 28. The secondary endpoint was relapse by 90 days after initial cure.
After initial treatment, 151 patients entered the randomization phase. At 28 days, relapse-free cure rates were nearly identical: 49% of the 12-day group and 50% of the 6-day group. However, by 90 days, a significant difference became apparent: Patients who had received the 6-day course of flucloxacillin were significantly more likely to have experienced a relapse of cellulitis in the same region (23.5% vs. 6% in the 12-day group). A Kaplan-Meier analysis showed that these patients began to relapse as early as 35 days after the end of therapy. Most relapses occurred during days 60-90. The few relapses in the 12-day group occurred toward the end of the follow-up period, from day 75 onward.
Dr. Cranendonk said the investigation shows that older, less-healthy cellulitis patients can probably benefit from the longer course of antibiotics. “Short-term outcomes aren’t everything,” he noted.
He had no financial disclosures.
A video interview of Dr. Cranendock by ECCMID 2018 is available.
SOURCE: Cranendonk et al. ECCMID 2018, Abstract O1122
MADRID – An attempt to balance effective treatment with good antibiotic stewardship fell short when patients with cellulitis who got 6 days of flucloxacillin relapsed significantly sooner and more frequently than did those who received the standard 12 days of treatment.
While cellulitis cure rates at 14 and 28 days were similar between the two groups, 90-day relapse rates were significantly higher for those who took the 6-day course (23.5% vs. 6%), Duncan R. Cranendonk, MD, said at the European Congress of Clinical Microbiology and Infectious Diseases annual conference. The cohort demographics perhaps played into this finding: Most of the group was elderly, hospitalized, and had comorbid conditions.
“However, this is the population clinicians are most likely to see,” said Dr Cranendonk of the University of Amsterdam. “It appears that therapy cannot be safely shortened in this population.”
In light of recent antibiotic trials showing that shorter courses can be as effective as prolonged treatment, Dr. Cranendonk and his colleagues conducted the DANCE (Duration of Antibiotic Therapy for Cellulitis) trial. The study investigated the efficacy of an abbreviated course of intravenous flucloxacillin among 248 patients with cellulitis admitted to 11 Dutch hospitals. At treatment day 6, those who had clinically improved after their initial treatment were randomized to 6 additional days of IV flucloxacillin or to placebo. The primary outcome was cure by day 14 without relapse by day 28.
A 2004 study successfully paved the way for DANCE, Dr. Cranendonk noted. That trial examined 5 versus 10 days of levofloxacin 500 mg for uncomplicated cellulitis in 87 patients. The outcome was positive: There was no significant difference in clinical outcome between the two arms, with a 98% cure rate in both groups.
However, Dr. Cranendonk noted, there were some important differences between the patients in that study and the DANCE cohort. They were, on the whole, younger and generally in better overall health. Also, only 15% of those patients were hospitalized for their infections, while all of the DANCE subjects were treated in the hospital.
Patients enrolled in DANCE were a mean of 62 years old, with a median 28 kg/m2 body mass index. About 40% had experienced cellulitis before, and 25% had diabetes. Most infections were on the leg (84%) and involved the lower leg or the lower leg and the foot. Fever was present in half of the group, lymphadenopathy in a third, and leukocytosis in 70%.
Upon enrollment, all 248 patients received 6 days of 1,000 mg/day IV flucloxacillin, with the option of a step-down to oral treatment (500 mg four times per day) at the treating physician’s discretion. At day 6, patients who were clinically improved (afebrile, no need to an antibiotic switch, no growth in blood culture, and improved symptoms of pain, ulceration, discharge, and fluctuance) were randomized to either another 6 days of flucloxacillin or placebo.
The primary endpoint was cure by day 14, with no relapse and no need for new antibiotics by day 28. The secondary endpoint was relapse by 90 days after initial cure.
After initial treatment, 151 patients entered the randomization phase. At 28 days, relapse-free cure rates were nearly identical: 49% of the 12-day group and 50% of the 6-day group. However, by 90 days, a significant difference became apparent: Patients who had received the 6-day course of flucloxacillin were significantly more likely to have experienced a relapse of cellulitis in the same region (23.5% vs. 6% in the 12-day group). A Kaplan-Meier analysis showed that these patients began to relapse as early as 35 days after the end of therapy. Most relapses occurred during days 60-90. The few relapses in the 12-day group occurred toward the end of the follow-up period, from day 75 onward.
Dr. Cranendonk said the investigation shows that older, less-healthy cellulitis patients can probably benefit from the longer course of antibiotics. “Short-term outcomes aren’t everything,” he noted.
He had no financial disclosures.
A video interview of Dr. Cranendock by ECCMID 2018 is available.
SOURCE: Cranendonk et al. ECCMID 2018, Abstract O1122
REPORTING FROM ECCMID 2018
Key clinical point: Elderly patients with cellulitis and comorbid conditions probably need a full 12-day course of treatment.
Major finding: Three-month relapse rates were significantly higher in those who received 6 days of flucloxacillin than they were among those who received 12 days (23.5% vs. 6%).
Study details: Patients who improved on 6 days of treatment were randomized to either placebo or another 6 days of therapy.
Disclosures: Dr. Cranendonk had no financial disclosures.
Source: Cranendonk DR et al. ECCMID 2018, Abstract O1122