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

Primary Purpose

Foot Infections in Diabetic Patients

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

MK0826, ertapenem sodium / Duration of Treatment - 24 weeks

Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeks

About this trial

This is an interventional treatment trial for Foot Infections in Diabetic Patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Outcomes

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.

Full Information

NCT ID

NCT00229112

First Posted

September 27, 2005

Last Updated

February 16, 2017

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00229112

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

April 2001 (undefined)

Primary Completion Date

April 2004 (Actual)

Study Completion Date

April 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Foot Infections in Diabetic Patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

400 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

MK0826, ertapenem sodium / Duration of Treatment - 24 weeks

Intervention Type

Drug

Intervention Name(s)

Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeks

Primary Outcome Measure Information:

Title

Clinical Cure/Improvement at discontinuation of IV antibiotic therapy.

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

17609322

Citation

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. doi: 10.1128/JCM.00551-07. Epub 2007 Jul 3.

Results Reference

background

PubMed Identifier

17199766

Citation

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. doi: 10.1111/j.1742-481X.2006.00269.x.

Results Reference

background

PubMed Identifier

17425547

Citation

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. doi: 10.1111/j.1742-481X.2006.00274.x.

Results Reference

background

PubMed Identifier

19671126

Citation

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.

Results Reference

background

PubMed Identifier

16291062

Citation

Lipsky BA, Armstrong DG, Citron DM, Tice AD, Morgenstern DE, Abramson MA. Ertapenem versus piperacillin/tazobactam for diabetic foot infections (SIDESTEP): prospective, randomised, controlled, double-blinded, multicentre trial. Lancet. 2005 Nov 12;366(9498):1695-703. doi: 10.1016/S0140-6736(05)67694-5.

Results Reference

result

Available IPD and Supporting Information:

Available IPD/Information Type

CSR Synopsis

Available IPD/Information URL

http://www.merck.com/clinical-trials/policies-perspectives.html

Learn more about this trial

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

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