| 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. |
| 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 |
| 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. |
| Not Provided |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment |
- Bacterial Infections
- Diabetic Foot
- Osteomyelitis
|
- 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).
|
|
|
| Lauf L, Ozsvár Z, Mitha I, Regöly-Mérei J, Embil JM, Cooper A, Sabol MB, Castaing N, Dartois N, Yan J, Dukart G, Maroko R. Phase 3 study comparing tigecycline and ertapenem in patients with diabetic foot infections with and without osteomyelitis. Diagn Microbiol Infect Dis. 2014 Apr;78(4):469-80. doi: 10.1016/j.diagmicrobio.2013.12.007. Epub 2013 Dec 16. |
| |
| Completed |
| 1061 |
| March 2009 |
| March 2009 (Final data collection date for primary outcome measure) |
|
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.
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Panama, Peru, Poland, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States |
| |
| |
| NCT00366249 |
| 3074K5-319 |
| Yes |
| Not Provided |
| Not Provided |
| Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
| Wyeth is now a wholly owned subsidiary of Pfizer |
| Not Provided |
| Study Director: |
Medical Monitor |
Wyeth is now a wholly owned subsidiary of Pfizer |
| Principal Investigator: |
Trial Manager |
For Belgium, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Hungary, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Spain, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Taiwan, [email protected]
|
| Principal Investigator: |
Trial Manager |
For South Africa, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Canada, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Australia, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Austria, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Croatia, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Latvia, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Lithuania, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Romania, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Argentina, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Brazil, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Chile, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Mexico, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Sweden, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Germany, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Denmark, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Estonia, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Finland, [email protected]
|
| Principal Investigator: |
Trial Manager |
For France, in[email protected]
|
| Principal Investigator: |
Trial Manager |
For UK/Great Britian: [email protected]
|
| Principal Investigator: |
Trial Manager |
For Switzerland, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Greece, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Italy, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Poland, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Russia, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Slovakia, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Turkey, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Ukraine, [email protected]
|
| Principal Investigator: |
Trial Manager |
For China, [email protected]
|
|
| Wyeth is now a wholly owned subsidiary of Pfizer |
| April 2010 |
