CompletedPhase 3

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.

United States1,061 participantsStarted 2007-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Patients With Clinical Response of Cure Vs. Failure.

Timeframe: Test of cure visit (TOC): Assessed at least 12 days post last dose

Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.

Timeframe: Test of cure visit (TOC): Assessed at least 12 days post last dose

Trial details

NCT IDNCT00366249

SponsorWyeth is now a wholly owned subsidiary of Pfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-03

Results submitted2009-07-14

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