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Background Ertapenem, a long-acting carbapenem, may be an alternative to the recommended prophylactic antibiotic cefotetan.
Methods In this randomized, double-blind trial, we assessed the efficacy and safety of antibiotic prophylaxis with ertapenem, as compared with cefotetan, in patients undergoing elective colorectal surgery. A successful outcome was defined as the absence of surgical-site infection, anastomotic leakage, or antibiotic use 4 weeks postoperatively. All adverse events were collected until 14 days after the administration of antibiotic prophylaxis.
Results Of the 1002 patients randomly assigned to study groups, 901 (451 in the ertapenem group and 450 in the cefotetan group) qualified for the modified intention-to-treat analysis, and 672 (338 in the ertapenem group and 334 in the cefotetan group) were included in the per-protocol analysis. After adjustment for strata, in the modified intention-to-treat analysis, the rate of overall prophylactic failure was 40.2% in the ertapenem group and 50.9% in the cefotetan group (absolute difference, –10.7%; 95% confidence interval [CI], –17.1 to –4.2); in the per-protocol analysis, the failure rate was 28.0% in the ertapenem group and 42.8% in the cefotetan group (absolute difference, –14.8%; 95% CI, –21.9 to –7.5). Both analyses fulfilled statistical criteria for the superiority of ertapenem. In the modified intention-to-treat analysis, the most common reason for failure of prophylaxis in both groups was surgical-site infection: 17.1% in the ertapenem group and 26.2% in the cefotetan group (absolute difference, –9.1; 95% CI, –14.4 to –3.7). In the treated population, the overall incidence of Clostridium difficile infection was 1.7% in the ertapenem group and 0.6% in the cefotetan group (P=0.22).
Conclusions Ertapenem is more effective than cefotetan in the prevention of surgical-site infection in patients undergoing elective colorectal surgery but may be associated with an increase in C. difficile infection. (ClinicalTrials.gov number, NCT00090272
[ClinicalTrials.gov]
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Source Information
From the Veterans Affairs Boston Healthcare System and Boston University Medical School, Boston (K.M.F.I.); the University of California, Irvine, School of Medicine, Orange (S.E.W.); Baylor College of Medicine and Michael E. DeBakey Veterans Affairs Medical Center, Houston Healthcare System, Houston (S.S.A.); and Merck Research Laboratories, Upper Gwynedd, PA (E.H.J., T.S.F., M.A.A.).
Address reprint requests to Dr. Itani at the Veterans Affairs Boston Healthcare System, 1400 VFW Pkwy., 112A, West Roxbury, MA 02132, or at kitani{at}med.va.gov.
Related Letters:
Antibiotic Prophylaxis in Colorectal Surgery
Moine P., Asehnoune K., Spievack A. R., Itani K. M.F., Abramson M. A.
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N Engl J Med 2007;
356:1684-1685, Apr 19, 2007.
Correspondence
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