drugset / Trial / NCT01370616

Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)

NCT01370616

Phase 3 Completed 565 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This study compared ertapenem sodium to piperacillin/tazobactam sodium for the treatment of moderate to severe diabetic foot infections. The primary hypothesis was that treatment with ertapenem sodium is non-inferior to treatment with piperacillin/tazobactam sodium, in achieving clinical improvement or cure.

Timeline

Start
2011-09-02
Primary completion
2013-12-08
Completion
2013-12-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Ertapenem Small molecule 1 g Intravenous
Comparator piperacillin/tazobactam Unknown 4.5 g Intravenous
Background Amoxicillin Other / unclassified 625 mg Oral

Indications