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Tigecycline is efficacious in the treatment of complicated intra-abdominal infections

Opened Access Tigecycline is efficacious in the treatment of complicated intra-abdominal infections

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Autor: Fomin,Peter
Beuran, Mircea
Gradauskas, Audrius
Barauskas, Giedrius
Dartois, Nathalie
Capitan-Morales, Luis-Cristobal
Departamento: Universidad de Sevilla. Departamento de Cirugía
Fecha: 2005
Publicado en: International journal of surgery, 3(1), 35-47
Tipo de documento: Artículo
Resumen: Background Empiric treatment of complicated intra-abdominal infections (cIAI) represents a clinical challenge because of the diverse bacteriology and the emergence of bacterial resistance. The efficacy and safety of tigecycline (TGC), a first-in-class, expanded broad-spectrum glycylcycline antibiotic, were compared with imipenem/cilastatin (IMI/CIS) in patients with cIAI. Methods In this prospective, double-blind, phase 3, multinational trial, patients were randomly assigned to intravenous (IV) TGC (100 mg initial dose, then 50 mg every 12 h) or IV IMI/CIS (500/500 mg every 6 h) for 5–14 days. Clinical response was assessed at the test-of-cure (TOC) visit (14–35 days after therapy) for microbiologically evaluable (ME) and microbiologically modified intent-to-treat (m-mITT) populations (co-primary efficacy endpoint populations in which cure/failure response rates were determined). Results Of 817 mITT patients (i.e., received ≥ 1 dose of study drug), 641 (78%) comprised the m...
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Tamaño: 274.3Kb
Formato: PDF

URI: http://hdl.handle.net/11441/42320

DOI: http://dx.doi.org/10.1016/j.ijsu.2005.03.011

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