Comparative Study of Ertapenem Versus Another Antibiotic in the Treatment of Diabetic Foot Infections in Adults (0826-034)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Foot Infections in Diabetic Patients
Intervention: MK0826, ertapenem sodium / Duration of Treatment - 24 weeks (Drug); Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeks (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
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.
Clinical Details
Official title: 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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Clinical Cure/Improvement at discontinuation of IV antibiotic therapy.
Secondary outcome: Clinical Cure: 1. Day 5 of IV antibiotic therapy; 2.10 days after completion of all antibiotic therapy.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Related publications: Citron DM, Goldstein EJ, Merriam CV, Lipsky BA, Abramson MA. Bacteriology of moderate-to-severe diabetic foot infections and in vitro activity of antimicrobial agents. J Clin Microbiol. 2007 Sep;45(9):2819-28. Epub 2007 Jul 3. Armstrong DG, Lipsky BA, Polis AB, Abramson MA. Does dermal thermometry predict clinical outcome in diabetic foot infection? Analysis of data from the SIDESTEP* trial. Int Wound J. 2006 Dec;3(4):302-7. Lipsky BA, Sheehan P, Armstrong DG, Tice AD, Polis AB, Abramson MA. Clinical predictors of treatment failure for diabetic foot infections: data from a prospective trial. Int Wound J. 2007 Mar;4(1):30-8. Lipsky BA, Polis AB, Lantz KC, Norquist JM, Abramson MA. The value of a wound score for diabetic foot infections in predicting treatment outcome: a prospective analysis from the SIDESTEP trial. Wound Repair Regen. 2009 Sep-Oct;17(5):671-7. doi: 10.1111/j.1524-475X.2009.00521.x. Epub 2009 Aug 11.
Starting date: April 2001
Last updated: November 12, 2014
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