At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium in the Treatment of Diabetic Foot Infections in Chinese Adults
In Brief
A Phase 3 clinical trial evaluating Ertapenem sodium, Piperacillin/tazobactam sodium, and 2 other interventions for Infection; Diabetic Foot. Completed, enrolled 565 participants.
Detailed 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.
Study Details
Timeline
Interventions
Ertapenem sodium, 1.0 g IV daily over 30 minutes at Hour 0 for 5 to 28 days
Piperacillin/tazobactam sodium, 4.5 g, IV every 8 hours, given over 30 minutes at Hours 0, 8, and 16 for 5 to 28 days
Placebo, IV over 30 minutes, 2 times per day at Hours 8 and 16 for 5 to 28 days
If clinically indicated, participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28