Phase 3
Completed N=1,061
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.
Source: ClinicalTrials.gov NCT00366249 ↗Enrolled (actual)
1,061
Serious AEs
—
Results posted
Aug 2009
Primary outcomePrimary: Number of Patients With Clinical Response of Cure Vs. Failure. — 316; 334; 92; 71 patients
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.
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 | — |
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.
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. Informational only — not medical advice.