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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00229112
First received: September 27, 2005
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Foot Infections in Diabetic Patients
Drug: MK0826, ertapenem sodium / Duration of Treatment - 24 weeks
Drug: Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Clinical Cure/Improvement at discontinuation of IV antibiotic therapy.

Secondary Outcome Measures:
  • Clinical Cure: 1. Day 5 of IV antibiotic therapy; 2.10 days after completion of all antibiotic therapy.

Estimated Enrollment: 400
Study Start Date: March 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229112

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00229112     History of Changes
Other Study ID Numbers: 2005_083, MK0826-034
Study First Received: September 27, 2005
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Infection
Communicable Diseases
Diabetic Foot
Focal Infection
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Ertapenem
Piperacillin
Piperacillin-tazobactam combination product
Penicillanic Acid
Tazobactam
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014