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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.

Primary Purpose

Bacterial Infections, Diabetic Foot, Osteomyelitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Tigecycline

Ertapenem

About this trial

This is an interventional treatment trial for Bacterial Infections focused on measuring Diabetic foot infection, Osteomyelitis, Diabetes Complications, Foot ulcer, Skin infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.

Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.

Number of Patients With Microbiologic Response of Eradication.

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.

Full Information

NCT ID

NCT00366249

First Posted

August 17, 2006

Last Updated

April 22, 2010

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00366249

Brief Title

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.

Official Title

A Multicenter, Randomized, Double-Blind, Comparison Study of the Safety and Efficacy of a Once-Daily Dose of Tigecycline Versus Ertapenem for the Treatment of Foot Infections in Subjects With Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Infections, Diabetic Foot, Osteomyelitis

Keywords

Diabetic foot infection, Osteomyelitis, Diabetes Complications, Foot ulcer, Skin infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1061 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Tigecycline

Intervention Description

150 mg Tigecycline once-daily IV infusion for up to 28 days, or 42 days for the substudy wth osteomyelitis

Intervention Type

Drug

Intervention Name(s)

Ertapenem

Intervention Description

Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.

Description

Time Frame

Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose

Title

Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.

Description

Time Frame

Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose

Title

Number of Patients With Microbiologic Response of Eradication.

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: