Overview

Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. The co-primary efficacy endpoints were not met.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Treatments:
Ertapenem
Minocycline
Tigecycline
Criteria
Main inclusion criteria:

- Men and women aged 18 or older with diabetes and a qualifying foot infection. People
with evidence of a diabetic foot infection with osteomyelitis may qualify for the
osteomyelitis substudy arm.

Main exclusion criteria:

- People with additional significant disease, infection with resistant pathogens,
contraindication, or hypersensitivity to any test article or related antibiotic.