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- Title
Seven Versus 14 Days of Antibiotic Therapy for Uncomplicated Gram-negative Bacteremia: A Noninferiority Randomized Controlled Trial.
- Authors
Yahav, Dafna; Franceschini, Erica; Koppel, Fidi; Turjeman, Adi; Babich, Tanya; Bitterman, Roni; Neuberger, Ami; Ghanem-Zoubi, Nesrin; Santoro, Antonella; Eliakim-Raz, Noa; Pertzov, Barak; Steinmetz, Tali; Stern, Anat; Dickstein, Yaakov; Maroun, Elias; Zayyad, Hiba; Bishara, Jihad; Alon, Danny; Edel, Yonatan; Goldberg, Elad
- 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 This was a randomized, multicenter, open-label, noninferiority trial. Inpatients with gram-negative bacteremia, who were afebrile and hemodynamically stable for at least 48 hours, were randomized to receive 7 days (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 readmission or extended hospitalization (>14 days). The noninferiority margin was set at 10%. Results We included 604 patients (306 intervention, 298 control) between January 2013 and August 2017 in 3 centers in Israel and Italy. The source of the infection was urinary in 411 of 604 patients (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 of 306 patients (45.8%) in the 7-day group vs 144 of 298 (48.3%) in the 14-day group (risk difference, –2.6% [95% confidence interval, –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-course therapy arm. Conclusions In patients hospitalized with gram-negative bacteremia achieving clinical stability before day 7, an antibiotic course of 7 days was noninferior to 14 days. Reducing antibiotic treatment for uncomplicated gram-negative bacteremia to 7 days is an important antibiotic stewardship intervention. Clinical Trials Registration NCT01737320.
- Subjects
ISRAEL; ITALY; ANTIBIOTICS; DISEASE relapse; ANTI-infective agents; BACTEREMIA; CONFIDENCE intervals; DRUG utilization; ENTEROBACTERIACEAE; GRAM-negative bacterial diseases; HEALTH facilities; LENGTH of stay in hospitals; LIFE skills; MEDICAL cooperation; RESEARCH; RISK assessment; SUPPURATION; URINARY tract infections; RANDOMIZED controlled trials; TREATMENT effectiveness; TREATMENT duration; PATIENT readmissions; DISEASE complications; DISEASE risk factors
- Publication
Clinical Infectious Diseases, 2019, Vol 69, Issue 7, p1091
- ISSN
1058-4838
- Publication type
Article
- DOI
10.1093/cid/ciy1054