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

NCT ID: NCT00229112

Last Updated: 2017-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2004-04-30

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.

Conditions

Foot Infections in Diabetic Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

MK0826, ertapenem sodium / Duration of Treatment - 24 weeks

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: BACKGROUND

PMID: 17609322 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17199766 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17425547 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19671126 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16291062 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2005_083

Identifier Type: -

Identifier Source: secondary_id

0826-034

Identifier Type: -

Identifier Source: org_study_id