Phase 3 N=1,061 Randomized Triple-blind Treatment

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.

Bacterial Infections · Diabetic Foot · Osteomyelitis

Bottom Line

View on ClinicalTrials.gov: NCT00366249 ↗

Enrolled (actual)

1,061

Serious AEs

—

Results posted

Aug 2009

Primary outcome: Primary: Number of Patients With Clinical Response of Cure Vs. Failure. — 316; 334; 92; 71 patients

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Tigecycline (Drug); Ertapenem (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Clinical Response of Cure Vs. Failure.	316; 334; 92; 71	—
PRIMARY Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.	340; 363; 117; 86; 19; 17	—
SECONDARY Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.	12; 13; 26; 11	—
SECONDARY Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.	19; 21; 27; 12; 7; 0	—
SECONDARY Number of Patients With Microbiologic Response of Eradication.	209; 229	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00366249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.