Comparative Study of Ertapenem Versus Another Antibiotic in the Treatment of Diabetic Foot Infections in Adults (0826-034)

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the efficacy, safety and tolerability of intravenous ertapenem versus another intravenous antibiotic in the treatment of moderate to severe diabetic foot infections.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ertapenem; Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam

Criteria

Inclusion Criteria:

• Type 1 or 2 Diabetes Mellitus treated with diet or medication

• Clinically or microbiologically documented foot infection below the knee

• Osteomyelitic bone must be removed within 48 hours of study entry

Exclusion Criteria:

• Uncomplicated skin infections

• Infected burn wounds

• Necrotizing fascitis

• Wounds with gangrene that cannot be removed with debridement

• Infections of prosthetic materials

• Foreign materials that can not be removed by surgical debridement

• Patients with another antibiotic 3 days prior to enrollment without evidence of treatment failure and presence of a positive culture

• Insufficient blood flow to the limb requiring a revascularization procedure