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NCT00229112

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.

Completed Phase 3 Last updated 16 February 2017
What this trial tests

Phase 3 trial testing MK0826, ertapenem sodium / Duration of Treatment - 24 weeks in Foot Infections in Diabetic Patients in 400 participants. Completed in 1 April 2004.

Timeline
1 April 2001
Primary endpoint
1 April 2004
1 April 2004

Quick facts

Lead sponsorMerck Sharp & Dohme LLC
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment400
Start date1 April 2001
Primary completion1 April 2004
Estimated completion1 April 2004

Drugs / interventions tested

Conditions studied

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Foot Infections in Diabetic Patients. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Ertapenem versus piperacillin/tazobactam for diabetic foot infections (SIDESTEP): prospective, randomised, controlled, double-blinded, multicentre trial.
    Lipsky BA, Armstrong DG, Citron DM, Tice AD, et al · · 2005 · cited 161× · PMID 16291062 · DOI 10.1016/s0140-6736(05)67694-5

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Trials by the same sponsor.

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