Journal
NEW ENGLAND JOURNAL OF MEDICINE
Volume 372, Issue 21, Pages 1996-2005Publisher
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa1411162
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Funding
- National Institutes of Health [R01GM081510, T32 AI078875]
- 3M
- Pfizer
- Bayer
- Merck
- AstraZeneca
- Baxter
- Ortho-McNeil
- Targanta Therapeutics
- Schering-Plough
- Astellas
- CareFusion
- Durata Therapeutics
- Rib-X Pharmaceuticals
- Affinium Pharmaceuticals
- Tetraphase Pharmaceuticals
- R-Pharm
- Applied Medical
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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.
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