Status:
COMPLETED
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.
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Bacterial Infections
Diabetic Foot
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 e...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
1061 Patients enrolled
Trial Details
Trial ID
NCT00366249
Start Date
January 1 2007
End Date
March 1 2009
Last Update
April 28 2010
Active Locations (211)
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1
Los Angeles, California, United States, 90010
2
Los Angeles, California, United States, 91342
3
Northridge, California, United States, 91326
4
San Francisco, California, United States, 94115