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Medicine: Evidence-Based Research: Plenary Session
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Moderator: George T. Rodeheaver, PhD Abstract This session will present new evidence-based data from recently performed clinical trails to be chosen before the meeting. Dr. Rodeheaver will moderate the session and provide introductions where appropriate. (Presentation 23.1) The SIDESTEP study of diabetic foot infections: a multicenter, double-blinded, randomized, controlled trial of ertapenem versus piperacillin/tazobactam Benjamin A. Lipsky, MD, VA Puget Sound Health Care System, Seattle, Wash; David G. Armstrong, DPM, PhD, Rosalind Franklin University of Medicine, Chicago, Ill; Peter Sheehan, MD, New York University School of Medicine, New York, NY; Diane M. Citron, MS, RM Alden Research Laboratory, Santa Monica, Calif; Gabriel J. Halperin, DPM, Los Angeles Wound Care Center, Los Angeles, Calif; Alan D. Tice, MD, University of Hawaii, Honolulu, Hawaii; Tara Erb, MS; Norman Bohidar, PhD; Thomas R. King, MPH; David Morgenstern, PhD; Sandy Rawlins, MBA; Murray Abramson, MD, MPH, Merck & Co., Inc., West Point, Pa Background: Diabetic foot infections (DFIs) are common and serious, but few randomized, controlled trials have compared efficacy of different antibiotic regimens for these frequently polymicrobial infections. Most previous studies were small and not masked. Methods: We compared intravenous (IV) E (1g/d), a group 1 carbapenem, and piperacillin/tazobactam (P/T) (3.375g qid) for treatment of patients with moderate to severe DFI in a double-masked study designed to determine noninferiority of E to P/T for DFI. Intravenous antibiotic therapy was required for a minimum of 5 days. Patients could be switched to oral therapy (amoxicillin/clavulanate) for a maximum cumulative treatment of 28 days. Baseline and follow-up visits included evaluation of tissue wound cultures, quantitative wound scores, digital photography, dermal thermography, and hematological studies. The primary endpoint was the percentage of patients with a favorable clinical response (cure or improvement) at the visit during which the IV antibiotic was discontinued (DCIV). Additional assessments were made at 10 days of follow up. Results: Five hundred seventy six patients were randomized to treatment (E: 289; P/T: 287), and 466 were evaluable at the end of IV therapy (E: 238; P/T: 228). Clinical success rates were similar between the treatments at DCIV (E: 94.3+3%, P/T: 92.3+3.5%); between treatment difference, (2.0; 95% CI: -2.7, 6.9). Similar clinical success rates were also observed in the 410 patients evaluable at 10-day follow-up assessment (E: 87.7%, P/T: 82.8%); between treatment difference, (4.8; 95% CI: -2.0, 11.9). During parenteral therapy, there was no difference in incidence of drug-related clinical adverse experiences (E: 15.2%, P/T: 19.9%) or in serious clinical drug-related adverse experiences (E: 0.3%, P/T: 0.3%). Conclusion: This study, the largest, most comprehensive, and only double-blinded, randomized, controlled trial of antibiotics for DFI, found that clinical and microbiological outcomes for patients treated with E once daily were equivalent to that of patients treated with P/T q 6 h. |
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