Conditions: Infection; Diabetic Foot
Keywords: Infection Diabetes complications Diabetes wound infection Soft tissue infection Osteomyelitis Diabetes mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 565
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants received 1.0 g intravenous (IV) ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28 arm 2: Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28

Interventions: intervention 1: Ertapenem sodium intervention 2: Piperacillin/tazobactam sodium intervention 3: Piperacillin/tazobactam-matching placebo intervention 4: Amoxicillin/clavulunate potassium
Intervention descriptions: intervention 1: Ertapenem sodium, 1.0 g IV daily over 30 minutes at Hour 0 for 5 to 28 days intervention 2: 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 intervention 3: Placebo, IV over 30 minutes, 2 times per day at Hours 8 and 16 for 5 to 28 days intervention 4: If clinically indicated, participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28

Protocol document: