NCT01370616View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

565

Participants

Timeline

Start Date

September 2, 2011

Primary Completion Date

December 8, 2013

Study Completion Date

December 18, 2013

Conditions
Infection; Diabetic Foot
Interventions
DRUG

Ertapenem sodium

Ertapenem sodium, 1.0 g IV daily over 30 minutes at Hour 0 for 5 to 28 days

DRUG

Piperacillin/tazobactam sodium

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

DRUG

Piperacillin/tazobactam-matching placebo

Placebo, IV over 30 minutes, 2 times per day at Hours 8 and 16 for 5 to 28 days

DRUG

Amoxicillin/clavulunate potassium

If clinically indicated, participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01370616 - Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061) | Biotech Hunter | Biotech Hunter