Status:
COMPLETED
Comparative Study of Ertapenem Versus Another Antibiotic in the Treatment of Diabetic Foot Infections in Adults (0826-034)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Foot Infections in Diabetic Patients
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
End Date :
April 1 2004
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00229112
Start Date
April 1 2001
End Date
April 1 2004
Last Update
February 17 2017
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