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

Phase 3

Completed

• Conditions: Foot Infections in Diabetic Patients

• Registration Number: NCT00229112
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-04
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Study First Submitted: 2005-09-27
• Study First Submitted QC: 2005-09-27
• Study First Posted: 2005-09-29
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical Cure/Improvement at discontinuation of IV antibiotic therapy.

Secondary Outcome Measures

Name	Time	Method
Clinical Cure: 1. Day 5 of IV antibiotic therapy; 2.10 days after completion of all antibiotic therapy.