Subjects with diabetes with a qualifying foot infection. MedDRA version: 9.1 Level: LLT Classification code 10060803 Term: Diabetic foot infection
Conditions
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Hospitalized male or female subjects >=18 years of age. 2. Subjects with diabetes mellitus per the American Diabetes Association (ADA) criteria. 3. Subjects with a foot infection that does not extend above the knee. If multiple infections meet all criteria below, the one with the highest IWGDF PEDIS grade for infection will be designated as the target. 4. Subjects with a foot infection that meets all of the following IWGDF PEDIS classifications (note: an ulcer is not required): · Perfusion: grade 1 or 2; · Infection: grades 2 to 4. Note: For regions that are only participating in the primary study and not the osteomyelitis substudy, subjects may not have evidence of a bone infection. 5. Subjects with anticipated need for IV antibiotic therapy of 5 days or longer. 6. Subjects whose foot infection has had an acute onset or worsening of signs and symptoms within the past 14 days. 7. Subjects who have received =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Necrotizing fasciitis, crepitant cellulitis, wet gangrene, gas gangrene, ecthyma gangrenosum, or severely impaired arterial supply to any portion of the affected foot. 2. Infected prosthetic materials or devices that will not be removed. 3. Suspected or known infection with a pathogen resistant to tigecycline or ertapenem ± vancomycin (eg, P. aeruginosa). 4. Subjects with a. a diabetic foot infection without presumptive evidence of osteomyelitis (as defined above) who are anticipated to need > 28 days of antibiotic treatment. (primary study arm) OR b. a diabetic foot infection with presumptive evidence of osteomyelitis (as defined above) who are anticipated to need > 42 days of antibiotic treatment.(applies only to regions and subjects participating in the osteomyelitis substudy arm). 5. Anticipated requirement for amputation (ie, removal of all infected tissue with clean margins) of the infected anatomical site within 1 month (30 days). 6. Concurrent hemodialysis, hemofiltration, peritoneal dialysis or plasmapheresis. 7. Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed (eg, life expectancy 10 x the upper limit of normal (ULN); ii. Total bilirubin > 3 x the ULN; iii. Acute hepatic failure or acute decompensation of chronic hepatic failure. c. Creatinine clearance (ClCR) 40 mg of prednisone or its equivalent per day for >3 weeks before randomization), or any severely immunocompromised subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the relative safety and clinical efficacy of a once-daily dose of tigecycline versus ertapenem in the treatment of subjects with diabetic foot infections. ;Secondary Objective: 1. To evaluate the microbiologic efficacy of tigecycline. 2. To obtain in vitro susceptibility data on tigecycline for a range of bacterial pathogens isolated from diabetic foot infections. 3. To compare health care resource utilization between treatment arms. 4. To examine the pharmacokinetic profile of tigecycline in subjects with diabetic foot infections after once-daily administration and after prolonged administration. 5. To evaluate the safety and efficacy of a once-daily dose of tigecycline in the treatment of subjects who are identified as having a diabetic foot infection with confirmed osteomyelitis.;Primary end point(s): The primary efficacy endpoint will be the clinical response rate at the Test-of-cure (TOC) visit for 2 co-primary populations: the Clinically evaluable (CE) population and the Clinical modified intent-to treat (c-mITT) population. | — |
Countries
Austria, Belgium, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed