NCT01370616.

Trial name or title	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
Methods	Phase III RCT, parallel assignment, double‐blind
Participants	Chinese participants with type I or II diabetes mellitus with clinically ‐ or bacteriologically ‐ documented moderate‐to‐severe (non‐life‐threatening) DFI that requires treatment with iv antibiotics
Interventions	Intervention: ertapenem sodium 1.0 g iv daily and piperacillin‐tazobactam‐matching placebo for 5 to 28 days Control: piperacillin‐tazobactam sodium 4.5 g iv every 6 h for 5 to 28 days Participants in both groups could be switched to oral antibiotics beginning on day 6 if clinically indicated
Outcomes	Primary outcomes Number of participants with clinical improvement of cure at the discontinuation of intravenous therapy visit
Starting date	September 2011
Contact information	Not provided. Responsible party and study sponsor: Merck Sharp & Dohme Corp
Notes	Primary completion date: December 2013. No publication available

Abbreviations

DFI: diabetic foot infection
 iv: intravenous
 MRSA: meticillin‐resistant Staphylococcus aureus 
 TOC: test‐of‐cure