7-day antibiotic course noninferior to 14-day course for gram-negative bacteremia
For patients with gram-negative bacteremia, a 7-day regimen of antibiotic therapy was noninferior to the standard 14-day treatment, according to findings presented at the European Congress of Clinical Microbiology and Infectious Diseases.
“Shorter therapy had no proven disadvantages,” Dafna Yahav, MD, of the Rabin Medical Center at Beilinson Hospital in Petah Tikva, Israel, said in a press release.
In a multicenter, open-label, noninferiority randomized controlled trial, researchers compared a 7-day antibiotic course (intervention group) with a 14-day course (control group) for patients with gram-negative bacteremia who were admitted to three hospitals in Italy and Israel between January 2013 and August 2017. Patients were excluded if sepsis was ongoing or if the source of the infection was uncontrolled. The noninferiority margin was 10% and, at 90 days, researchers evaluated all-cause mortality, clinical failure and readmission or extended hospital stay greater than 14 days — a composite primary outcome. According to the study, 30- and 90-day mortality, development of secondary infections, Clostridium difficile infection, total antibiotic days and hospital days, functional capacity, time to return to baseline activity and the development of resistance and adverse events were evaluated as secondary outcomes.
Of the 604 patients included in the study, the source of infection for 68% (n = 141) was urinary and for 90% (n = 543) the causative pathogen was Enterobacteriaceae. Patients were split between the intervention group (n = 306) and the control group (n = 298).
At the 90-day evaluation, the composite primary outcome developed in 46.1% (n = 141) of patients in the intervention group vs. 50% (n = 149) in the control group (absolute risk difference [ARD] = –3.9%; 95% CI, –11.9% to 4%). Total antibiotic days — measured from therapy initiation to 90 days after randomization — were significantly shorter in the intervention group (median, 5 days; interquartile range [IQR], 4-13 days) compared with the control group (median, 12 days; IQR, 10-16 days). Similarly, Yahav and colleagues found that patients in the intervention group took a median of 2 weeks (IQR, 0-8.3 weeks) to return to baseline activity, which was significantly shorter than for patients in the control group, who took a median of 3 weeks (IQR, 1-12 weeks). Additionally, the fatality rate at 90 days was not significantly different between either group and no other secondary outcomes were observed.
“This could lead to a change in accepted management algorithms and shortened antibiotic therapy,” Yahav said in the release. “Potentially, though we did not show that in our trial, it may lead to reduced cost, resistance development and adverse events.” – by Marley Ghizzone
Yahav D, et al. Abstract O1120. Presented at: European Congress of Clinical Microbiology and Infectious Diseases; April 21-24, 2018; Madrid.
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