Study Evaluating the Safety and Efficacy of a Once-Daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections with Osteomyelitus

This purpose of this study is to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections with 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

Conditions

Bacterial Infections, Diabetic Foot, Osteomyelitis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Clinical response rate (cure/failure rate) 14 to 21 days after the last dose of study antibiotic(s) for participants with diabetic foot infections without osteomyelitis.

Secondary Outcome Measures:

• Microbiologic efficacy, microbiologic susceptibility data, health care resource utilization, pharmacokinetic profile of 150 mg once-daily dose, clinical response rate for diabetic foot infections with osteomyelitis.

Study Start

September 2006; Expected completion: April 2008

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

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

Exclusion criteria:

• People with additional significant disease, infection with resistant pathogens, contraindication, or hypersensitivity to any test article or related antibiotic

Total Enrolment

781

Contact Details

• Box Hill, Victoria, 3128, Australia; Recruiting

Email the investigators:

• clintrialparticipation@wyeth.com
• medinfo@wyeth.com

Please refer to this study by ClinicalTrials.gov identifier: NCT00366249