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

• Conditions: Bacterial Infections; Diabetic Foot; Osteomyelitis
• Interventions: Drug: Tigecycline; Drug: Ertapenem

• Registration Number: NCT00366249
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-17
• Study First Submitted QC: 2006-08-17
• Study First Posted: 2006-08-21
• Study Start: 2007-01
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2009-07-14
• Results First Submitted QC: 2009-07-14
• Results First Posted: 2009-08-21
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-22
• Last Update Posted: 2010-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1061

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Tigecycline	-
B	Ertapenem	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With Clinical Response of Cure Vs. Failure.	Test of cure visit (TOC): Assessed at least 12 days post last dose	Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, \>120% doses, non-routine surgical treatment or death related to Diabetic Foot Infections (DFI) \> 48 hrs.
Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.	Test of cure visit (TOC): Assessed at least 12 days post last dose	Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, \>120% doses, non-routine surgical treatment or death related to DFI \> 48 hrs. Indeterminate: Lost to follow-up, death\<48 hours or noninfection related.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.	Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose	Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, \>120% doses, non-routine surgical treatment or death related to DFI \> 48 hrs.
Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.	Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose	Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, \>120% doses, non-routine surgical treatment or death related to DFI \> 48 hrs. Indeterminate: Lost to follow-up, death\<48 hours or noninfection related.
Number of Patients With Microbiologic Response of Eradication.	Test of cure visit (TOC): Assessed at least 12 days post last dose	Eradication defined as: no pathogen is present in the repeat culture from the original site of infection, or a clinical response of the cure precludes the availability of a specimen for culture.