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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Foot Infections in Diabetic Patients

Treatments

Drug: Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeks

Drug: MK0826, ertapenem sodium / Duration of Treatment - 24 weeks

Study type

Interventional

Funder types

Industry

Identifiers

NCT00229112

0826-034

2005_083

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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