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.
This study has been completed.
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
First received: August 17, 2006
Last updated: April 22, 2010
Last verified: April 2010
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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 3 |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Bacterial Infections
Diabetes
Diabetes Complications
Diabetic Foot
Foot Health
U.S. FDA Resources
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- Number of Patients With Clinical Response of Cure Vs. Failure. [ Time Frame: Test of cure visit (TOC): Assessed at least 12 days post last dose ] [ Designated as safety issue: No ]Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to Diabetic Foot Infections (DFI) > 48 hrs.
- Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate. [ Time Frame: Test of cure visit (TOC): Assessed at least 12 days post last dose ] [ Designated as safety issue: No ]Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs. Indeterminate: Lost to follow-up, death<48 hours or noninfection related.
Secondary Outcome Measures:
- Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose. [ Time Frame: Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose ] [ Designated as safety issue: No ]Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs.
- Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose. [ Time Frame: Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose ] [ Designated as safety issue: No ]Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs. Indeterminate: Lost to follow-up, death<48 hours or noninfection related.
- Number of Patients With Microbiologic Response of Eradication. [ Time Frame: Test of cure visit (TOC): Assessed at least 12 days post last dose ] [ Designated as safety issue: No ]Eradication defined as: no pathogen is present in the repeat culture from the original site of infection, or a clinical response of the cure precludes the availability of a specimen for culture.
| 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 |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366249
Show 211 Study Locations
Show 211 Study LocationsSponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| 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
No publications provided
| 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 |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Diabetic foot infection Osteomyelitis Diabetes Complications Foot ulcer Skin infection |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 19, 2013