None listed
Conditions
Interventions
GROUP A Type of group
This group will be treated with Tigecycline, at a dose of 150 mg, in an IV infusion, every 24 hours, up to a maximum of 28 consecutive days.
Group name:GROUP B Type of group
This group will be treated with Ertapenem, at a dose of 1 g, in an IV infusion, every 24 hours, up to a maximum of 28 consecutive days.
Sponsors
LABORATORIOS WYETH S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects, hospitalized, ≥18 years of age. 2. Subjects with diabetes mellitus. 3. Subjects with an infection in the foot that does not extend above the knee. 4. Subjects with a foot infection that meets all of the following classifications of the PEDIS index IWGDF: Perfusion: grade 1 or 2; Infection: grades 2 to 4. 5. Subjects with an anticipated need for IV antibiotic therapy of 5 days or more. 6. Subjects whose foot infections have had an acute onset or worsening of signs and symptoms within the past 14 days. 7. Subjects who have received ≤ 48 hours of a potentially effective antibiotic to treat the current target infection. 8. Subjects that are considered therapeutic failures of previous antibiotic therapies. 9. Branch osteomyelitis substudy: Subjects who have presumed evidence of osteomyelitis, or a positive finding in bone catheterization or confirmed evidence of osteomyelitis by MRI.
Exclusion criteria
Exclusion criteria: 1. Necrotizing fasciitis, wet gangrene, crepitating cellulitis, gas gangrene, gangrenous eczema and severely damaged arterial supply to any part 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 and vancomycin. 4. Subjects with: a) A diabetic foot infection without presumed evidence of osteomyelitis and in whom it is expected that they will need> 28 days of antibiotic treatment. OR b) A diabetic foot infection with presumed evidence of osteomyelitis in which it is anticipated that it will require> 42 days of antibiotic treatment. 5. Preliminary requirement for resection or complete amputation of the infected anatomical site within 1 month. 6. Hemodialysis, hemofiltration, peritoneal dialysis or simultaneous plasmapheresis. 7. Any concomitant condition that may prevent an evaluation of the response or make it unlikely that the course of therapy can be completed. 8. Subjects with contraindications or hypersensitivity to any of the drugs under study or related antibiotics. 9. Presence of any of the following laboratory findings: a) Neutropenia with an absolute neutrophil count <1 x 10-9 / L. b) Presence of significant liver disease. c) Clearance of creatinine (CLcr) <30 mL / min. 10. Known or suspected simultaneous infection that may require treatment with additional antibacterial systemic agent. 11. Any drug or research device used within 4 weeks prior to IV administration of the first dose of the study medication. 12. Previous participation in this study. 13. Pregnant or lactating women. 14. Potentially fertile women who do not agree to practice sexual abstinence or use a medically acceptable method of contraception for the entire duration of the study. 15. Subjects who are taking immunosuppressive therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation to determine the resolution of all signs and symptoms of infection or improvement to such a degree that no other antibacterial therapy is necessary to treat the target infection. Measure:Clinical response rate in the TOC visit. Timepoints:14 - 21 days after the last dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criteria 1, 2 and 3: Blood cultures, wound or others, in which eradication, persistence or indeterminate result will be identified. Criterion 4: Clinical or microbiological response (defined above) in case of polymicrobial / monomicrobial infections. Measure:1) Microbiological responses at the level of the subject and at the level of the pathogen. 2) Cure rate by basal pathogen. 3) Response rate by pathogen and basal MIC value. 4) Response rate for polymicrobial / monomicrobial infections. Timepoints:14 - 21 days after the last dose. ; Outcome name:Criterion 1: Complete physical examination, in case of open ulcers, an evaluation of osteomyelitis by means of bone catheterization will be included. Criterion 2: Measurement of blood pressure, heart rate, respiratory rate, and temperature. Criterion 3: Clinical evaluation of any undesirable medical event experienced by a patient to whom the investigational product has been administered. Criterion 4: Panels of serum chemistry and hematology. Criterion 5: Standard 12-lead electrocardiogram. Measure:Security: 1) Physical exams. 2) Vital signs. 3) Adverse effects. 4) Laboratory tests. 5) ECG. Timepoints:Criteria 1, 2 and 5: Days 1 and 3, last day of treatment and on day 42. Criteria 3 and 4: Days 1, 3, 6 last day of treatment and on day 42. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Italy, Korea South, Latovia, Lithuania, Mexico, Panama, Poland, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactEsperanza Mejia
LABORATORIOS WYETH S.A.
Outcome results
None listed