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

Merck Sharp & Dohme (MSD) logo

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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