Seven versus fourteen Days of Antibiotic Therapy for uncomplicated Gram-negative Bacteremia: a Non-inferiority Randomized Controlled Trial
Abstract
Background
Gram-negative bacteremia is a major cause of morbidity and mortality in hospitalized patients. Data to guide the duration of antibiotic therapy are limited.
Methods
Randomized, multicenter, open-label, non-inferiority trial. Inpatients with Gram-negative bacteremia, afebrile and hemodynamically stable for at least 48 hours, were randomized to receive 7 (intervention) or 14 days (control) of covering antibiotic therapy. Patients with uncontrolled focus of infection were excluded. The primary outcome at 90 days was a composite of all-cause mortality; relapse, suppurative or distant complications; and re-admission or extended hospitalization (>14 days). The non-inferiority margin was set at 10%.
Results
We included 604 patients (306 intervention, 298 control) between January 2013 and August 2017 in three centers in Israel and Italy. The source of the infection was urinary in 411/604 (68%); causative pathogens were mainly Enterobacteriaceae (543/604, 90%). A 7-day difference in the median duration of covering antibiotics was achieved. The primary outcome occurred in 140/306 (45.8%) patients in the 7 days group versus 144/298 (48.3%) in the 14 days group (risk difference [RD] -2.6%, 95% confidence interval [CI] -10.5% to 5.3%). No significant differences were observed in all other outcomes and adverse events, except for a shorter time to return to baseline functional status in the short therapy arm.
Conclusions
In patients hospitalized with Gram-negative bacteremia…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 604 participants or records.
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