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.

Wyeth is now a wholly owned subsidiary of Pfizer1,061 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

1,061

Conditions

Bacterial Infections Diabetic Foot Osteomyelitis

Interventions

ErtapenemDRUG

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (211)

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Northridge, California, United States

Unnamed facility

San Francisco, California, United States

Unnamed facility

Sylmar, California, United States

Unnamed facility

Outcomes

Primary Outcomes

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.

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

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

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

Secondary Outcomes

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

Time frame: Test of cure visit (TOC): 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.

Time frame: Test of cure visit (TOC): 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.

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