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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00229112
First Posted: September 29, 2005
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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: April 2001
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00229112


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

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00229112     History of Changes
Other Study ID Numbers: 0826-034
2005_083
First Submitted: September 27, 2005
First Posted: September 29, 2005
Last Update Posted: February 17, 2017
Last Verified: February 2017

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
Tazobactam
Piperacillin
Ertapenem
Piperacillin, tazobactam drug combination
Penicillanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action