Foot Infections in Diabetic Patients
Conditions
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.
Interventions
DRUGMK0826, ertapenem sodium / Duration of Treatment - 24 weeks
DRUGComparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Cure/Improvement at discontinuation of IV antibiotic therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Cure: 1. Day 5 of IV antibiotic therapy; 2.10 days after completion of all antibiotic therapy. | — |
Outcome results
None listed