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.
NCT00366249 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1061
Last updated 2010-04-28
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.
Conditions
- Bacterial Infections
- Diabetic Foot
- Osteomyelitis
Interventions
- DRUG
-
Tigecycline
150 mg Tigecycline once-daily IV infusion for up to 28 days, or 42 days for the substudy wth osteomyelitis
- DRUG
-
Ertapenem
Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
Sponsors & Collaborators
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Wyeth is now a wholly owned subsidiary of Pfizer
lead INDUSTRY
Principal Investigators
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Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer
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Trial Manager · For Belgium, [email protected]
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Trial Manager · For Hungary, [email protected]
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Trial Manager · For Spain, [email protected]
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Trial Manager · For Taiwan, [email protected]
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Trial Manager · For South Africa, [email protected]
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Trial Manager · For Canada, [email protected]
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Trial Manager · For Australia, [email protected]
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Trial Manager · For Austria, [email protected]
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Trial Manager · For Croatia, [email protected]
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Trial Manager · For Latvia, [email protected]
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Trial Manager · For Lithuania, [email protected]
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Trial Manager · For Romania, [email protected]
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Trial Manager · For Argentina, [email protected]
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Trial Manager · For Brazil, [email protected]
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Trial Manager · For Chile, [email protected]
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Trial Manager · For Mexico, [email protected]
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Trial Manager · For Sweden, [email protected]
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Trial Manager · For Germany, [email protected]
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Trial Manager · For Denmark, [email protected]
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Trial Manager · For Estonia, [email protected]
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Trial Manager · For Finland, [email protected]
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Trial Manager · For France, [email protected]
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Trial Manager · For UK/Great Britian: [email protected]
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Trial Manager · For Switzerland, [email protected]
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Trial Manager · For Greece, [email protected]
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Trial Manager · For Italy, [email protected]
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Trial Manager · For Poland, [email protected]
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Trial Manager · For Russia, [email protected]
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Trial Manager · For Slovakia, [email protected]
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Trial Manager · For Turkey, [email protected]
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Trial Manager · For Ukraine, [email protected]
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Trial Manager · For China, [email protected]
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-01-31
- Primary Completion
- 2009-03-31
- Completion
- 2009-03-31
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Canada
- Chile
- China
- Colombia
- Croatia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- India
- Italy
- Latvia
- Lithuania
- Mexico
- Panama
- Peru
- Poland
- Portugal
- Romania
- Russia
- Slovakia
- South Africa
- South Korea
- Spain
- Sweden
- Switzerland
- Taiwan
- Turkey (Türkiye)
- Ukraine
- United Kingdom
Study Locations
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