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| Sponsor: | Wyeth is now a wholly owned subsidiary of Pfizer |
|---|---|
| Information provided by: | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00366249 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bacterial Infections Diabetic Foot Osteomyelitis |
Drug: Tigecycline Drug: Ertapenem |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Comparison Study of the Safety and Efficacy of a Once-Daily Dose of Tigecycline Versus Ertapenem for the Treatment of Foot Infections in Subjects With Diabetes |
| Enrollment: | 1061 |
| Study Start Date: | January 2007 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A |
Drug: Tigecycline
150 mg Tigecycline once-daily IV infusion for up to 28 days, or 42 days for the substudy wth osteomyelitis
|
| Active Comparator: B |
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).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Main inclusion criteria:
Main exclusion criteria:
Contacts and Locations
Show 211 Study Locations| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Principal Investigator: | Trial Manager | For Belgium, trials-BEL@wyeth.com |
| Principal Investigator: | Trial Manager | For Hungary, WPBUMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Spain, infomed@wyeth.com |
| Principal Investigator: | Trial Manager | For Taiwan, medinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For South Africa, ZAFinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Canada, clintrialparticipation@wyeth.com |
| Principal Investigator: | Trial Manager | For Australia, medinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Austria, WPVIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Croatia, WPBUMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Latvia, WPVIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Lithuania, WPVIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Romania, WVPIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Argentina, Scheima@wyeth.com |
| Principal Investigator: | Trial Manager | For Brazil, xavierl@wyeth.com |
| Principal Investigator: | Trial Manager | For Chile, scheima@wyeth.com |
| Principal Investigator: | Trial Manager | For Mexico, gomezzlj@wyeth.com |
| Principal Investigator: | Trial Manager | For Sweden, MedInfoNord@wyeth.com |
| Principal Investigator: | Trial Manager | For Germany, medinfoDEU@wyeth.com |
| Principal Investigator: | Trial Manager | For Denmark, medinfonord@wyeth.com |
| Principal Investigator: | Trial Manager | For Estonia, WVPMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Finland, MedInfoNord@wyeth.com |
| Principal Investigator: | Trial Manager | For France, infomedfrance@wyeth.com |
| Principal Investigator: | Trial Manager | For UK/Great Britian: ukmedinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Switzerland, med@wyeth.com |
| Principal Investigator: | Trial Manager | For Greece, decresg@wyeth.com |
| Principal Investigator: | Trial Manager | For Italy, descresg@wyeth.com |
| Principal Investigator: | Trial Manager | For Poland, WPWZMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Russia, WVPIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Slovakia, DIS-WP-BV-EUBV01-Medical@wyeth.com |
| Principal Investigator: | Trial Manager | For Turkey, Erisc@wyeth.com |
| Principal Investigator: | Trial Manager | For Ukraine, WVPIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For China, medinfo@wyeth.com |
More Information
| Responsible Party: | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
| ClinicalTrials.gov Identifier: | NCT00366249 History of Changes |
| Other Study ID Numbers: | 3074K5-319 |
| Study First Received: | August 17, 2006 |
| Results First Received: | July 14, 2009 |
| Last Updated: | April 22, 2010 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Human Research Ethics Committee; Brazil: Ministry of Health; Canada: Health Canada; Chile: Instituto de Salud Publica de Chile; China: Ministry of Health; European Union: European Medicines Agency; Hong Kong: Department of Health; India: Ministry of Health; Korea: Food and Drug Administration; Mexico: Ethics Committee; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Singapore: Health Sciences Authority; South Africa: Medicines Control Council; Taiwan: Department of Health; United States: Food and Drug Administration |
|
Diabetic foot infection Osteomyelitis Diabetes Complications Foot ulcer Skin infection |
|
Bacterial Infections Osteomyelitis Diabetic Foot Focal Infection Bone Diseases, Infectious Infection Bone Diseases Musculoskeletal Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Foot Ulcer Leg Ulcer |
Skin Ulcer Skin Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies Ertapenem Tigecycline Minocycline Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
