Robert G Sawyer1, Jeffrey A Claridge, Avery B Nathens, Ori D Rotstein, Therese M Duane, Heather L Evans, Charles H Cook, Patrick J O'Neill, John E Mazuski, Reza Askari, Mark A Wilson, Lena M Napolitano, Nicholas Namias, Preston R Miller, E Patchen Dellinger, Christopher M Watson, Raul Coimbra, Daniel L Dent, Stephen F Lowry, Christine S Cocanour, Michaela A West, Kaysie L Banton, William G Cheadle, Pamela A Lipsett, Christopher A Guidry, Kimberley Popovsky. 1. From the Department of Surgery, University of Virginia Health System, Charlottesville (R.G.S., C.A.G., K.P.); the Department of Surgery, Virginia Commonwealth University, Richmond (T.M.D.); the Department of Surgery, Case Western Reserve University, Cleveland (J.A.C.); the Department of Surgery, University of Toronto, Toronto (A.B.N., O.D.R.); the Department of Surgery, University of Washington, Seattle (H.L.E., E.P.D.); the Department of Surgery, Beth Israel Deaconess Medical Center (C.H.C.), and the Department of Surgery, Brigham and Women's Hospital (R.A.) - both in Boston; the Department of Surgery, Maricopa Integrated Health System, Phoenix, AZ (P.J.O.); the Department of Surgery, Washington University, St. Louis (J.E.M.); the Department of Surgery, VA Pittsburgh Healthcare System, Pittsburgh (M.A. Wilson); the Department of Surgery, University of Michigan, Ann Arbor (L.M.N.); the Department of Surgery, University of Miami Miller School of Medicine, Miami (N.N.); the Department of Surgery, Wake Forest School of Medicine, Winston-Salem, NC (P.R.M.); the Department of Surgery, University of South Carolina, Columbia (C.M.W.); University of California, San Diego, San Diego (R.C.), the Department of Surgery, UC Davis Medical Center, Sacramento (C.S.C.), and the Department of Surgery, University of California, San Francisco, San Francisco (M.A. West) - all in California; the Department of Surgery, University of Texas Health Science Center at San Antonio, San Antonio (D.L.D.); the Department of Surgery, University of Medicine and Dentistry of New Jersey, Newark (S.F.L.); the Department of Surgery, University of Minnesota Medical School, Minneapolis (K.L.B.); the Department of Surgery, University of Louisville School of Medicine, Louisville, KY (W.G.C.); and the Department of Surgery, Johns Hopkins University School of Medicine, Baltimore (P.A.L.).
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 andadequate 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.).
RCT Entities:
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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