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.
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
Bacterial Infections, Diabetic Foot, Osteomyelitis
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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.
September 2006; Expected completion: April 2008
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and above
- Genders Eligible for Study: Both
- 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
- People with additional significant disease, infection with resistant pathogens, contraindication, or hypersensitivity to any test article or related antibiotic
- Box Hill, Victoria, 3128, Australia; Recruiting
Email the investigators:
Please refer to this study by ClinicalTrials.gov identifier: NCT00366249