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Telithromycin

CHOOSE : Telithromycin, Acute Bacterial Sinusitis

Ensayo de Sanofi en Sinusitis (del registro, en inglés).

Fase

Fase 4

Estado

Completado

Participantes

298

previstos

Fin del objetivo primario

dic 2005

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en nov 2004.

Qué mide

clinical success rate at the TOC visit in the per protocol population. (During all the study conduct) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary objective: * To demonstrate that the clinical efficacy of telithromycin (800 mg od for 5 days) is non-inferior to amoxicillin-clavulanic acid (875/125 mg bid for 10 days) at the test-of-cure (TOC) visit (Day 17-21) in subjects with acute bacterial sinusitis (ABS). Secondary objective(s): * To assess the time to resolution of signs and symptoms between the baseline (Day 1) and TOC (Day 17-21) visits, * To assess the rate of clinical relapse at the follow-up visit (Day 41-49), * To assess health economic outcome until follow-up visit (Day 41-49), * To assess quality of life up to the follow-up visit (Day 41-49), * To compare the safety of telithromycin and amoxicillin-clavulanic acid, * To compare the bacteriologic outcome of both treatments as observed at TOC (Day 17-21) and at follow-up visit (Day 41-49),in subjects with ABS.

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Ficha completa en ClinicalTrials.gov (NCT00174694), actualizada en sep 2009.