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.

Phase 3 Completed 1061 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2007-01
Primary completion: 2009-03
Completion: 2009-03

Publications

Lauf L, Ozsvar Z, Mitha I, Regoly-Merei 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ertapenem	Small molecule	1000 mg	Intravenous
Comparator	Tigecycline	Small molecule	150 mg	Intravenous

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.

Summary

Timeline

Publications

Drugs

Indications