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.
Status and phase
Completed
Phase 3
Conditions
Diabetic Foot
Osteomyelitis
Bacterial Infections
Treatments
Drug: Ertapenem
Drug: Tigecycline
Details and patient eligibility
About
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.
Enrollment
1,061 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Triple Blind
1,061 participants in 2 patient groups
A
Active Comparator group
Treatment:
Drug: Tigecycline
B
Active Comparator group
Treatment:
Drug: Ertapenem
Trial contacts and locations
211
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Data sourced from clinicaltrials.gov
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