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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00366249Tipo: INTERVENTIONALInicio: 1 de ene de 2007Fin estimado: 1 de mar de 2009

Endocrinología Dermatología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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

Intervenciones

drug

Tigecycline

150 mg Tigecycline once-daily IV infusion for up to 28 days, or 42 days for the substudy wth osteomyelitis

drug

Ertapenem

Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).

Ubicaciones

Buenos Aires, Buenos Aires, Argentina

Chivilcoy, Buenos Aires, Argentina

Ciudadela, 3 de Febrero, Buenos Aires, Argentina

La Plata, Buenos Aires, Argentina

Loma Hermosa, Buenos Aires, Argentina

Mar del Plata, Buenos Aires, Argentina

Merlo, Buenos Aires, Argentina

Morón, Buenos Aires, Argentina

Paraná, Entre Ríos Province, Argentina

Tunuyán, Mendoza Province, Argentina

Rosario, Santa Fe Province, Argentina

San Miguel de Tucumán, Tucumán Province, Argentina

Buenos Aires, Argentina

Córdoba, Argentina

Mendoza, Argentina

Patrocinadores

PrincipalWyeth is now a wholly owned subsidiary of Pfizer

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