Trial of Short-Course Antimicrobial Therapy for Intraabdominal Infection

Robert G. Sawyer(Virginia Commonwealth University), Jeffrey A. Claridge(Virginia Commonwealth University), Avery B. Nathens(Virginia Commonwealth University), Ori D. Rotstein(Virginia Commonwealth University), Therèse M. Duane(Virginia Commonwealth University), Heather L. Evans(Virginia Commonwealth University), Charles H. Cook(Virginia Commonwealth University), Patrick J. O’Neill(Virginia Commonwealth University), John E. Mazuski(Virginia Commonwealth University), Reza Askari(Brigham and Women's Hospital), Mark A. Wilson(Virginia Commonwealth University), Lena M. Napolitano(Virginia Commonwealth University), Nicholas Namias(University of Miami), Preston R. Miller(Virginia Commonwealth University), E. Patchen Dellinger(Virginia Commonwealth University), Christopher M. Watson(University of South Carolina), Raúl Coimbra(Virginia Commonwealth University), Daniel L. Dent(The University of Texas at San Antonio Health Science Center), Stephen F. Lowry(Virginia Commonwealth University), Christine S. Cocanour(Virginia Commonwealth University), Michael A. West(University of California, San Francisco), Kaysie L. Banton(Virginia Commonwealth University), William G. Cheadle(University of Louisville), Pamela A. Lipsett(Johns Hopkins University), Christopher A. Guidry(Virginia Commonwealth University), Kimberley A. Popovsky(Virginia Commonwealth University)
New England Journal of Medicine
May 20, 2015
Cited by 728Open Access
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Abstract

BACKGROUND: The successful treatment of intraabdominal infection requires a combination of anatomical source control and antibiotics. The appropriate duration of antimicrobial therapy remains unclear. METHODS: We randomly assigned 518 patients with complicated intraabdominal infection and adequate source control to receive antibiotics until 2 days after the resolution of fever, leukocytosis, and ileus, with a maximum of 10 days of therapy (control group), or to receive a fixed course of antibiotics (experimental group) for 4±1 calendar days. The primary outcome was a composite of surgical-site infection, recurrent intraabdominal infection, or death within 30 days after the index source-control procedure, according to treatment group. Secondary outcomes included the duration of therapy and rates of subsequent infections. RESULTS: Surgical-site infection, recurrent intraabdominal infection, or death occurred in 56 of 257 patients in the experimental group (21.8%), as compared with 58 of 260 patients in the control group (22.3%) (absolute difference, -0.5 percentage point; 95% confidence interval [CI], -7.0 to 8.0; P=0.92). The median duration of antibiotic therapy was 4.0 days (interquartile range, 4.0 to 5.0) in the experimental group, as compared with 8.0 days (interquartile range, 5.0 to 10.0) in the control group (absolute difference, -4.0 days; 95% CI, -4.7 to -3.3; P<0.001). No significant between-group differences were found in the individual rates of the components of the primary outcome or in other secondary outcomes. CONCLUSIONS: In patients with intraabdominal infections who had undergone an adequate source-control procedure, the outcomes after fixed-duration antibiotic therapy (approximately 4 days) were similar to those after a longer course of antibiotics (approximately 8 days) that extended until after the resolution of physiological abnormalities. (Funded by the National Institutes of Health; STOP-IT ClinicalTrials.gov number, NCT00657566.).


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