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

A Prospective, Multicenter, Double-Blind With In-House Blinding, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability, of Ertapenem Versus Piperacillin/Tazobactam in the Treatment of Diabetic Foot Infections in Adults.

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.

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