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Levofloxacin

LEVOS - Levofloxacin and Rifampicin Therapy in the Treatment of OsteoArticular Prothethic Infection

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

Fase

Fase 3

Estado

Interrumpido

Participantes

10

previstos

Centros

1

Fin del objetivo primario

abr 2010

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en abr 2009.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «lack of recruitment».

Qué mide

Microbiological success defined as the percentage of patients with negative peri-operative bacteriological samples and the absence of clinical, biological or radiological signs of infection. (During the reimplantation of the new prosthesis i.e. 15 days to 3 months after the end of treatment) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective is: to assess the microbiological success of the combination of levofloxacin and rifampicin, administered for 32 to 37 days, as oral replacement therapy of an empirical antibiotic therapy of a maximum of 5 to 10 days given intravenously, in the treatment of OsteoArticular Prosthetic Infections (OAPI), with a two-stage revision of the prosthesis. The secondary endpoints are: * To assess the rate of clinical failure 12 months after the reimplantation of the prosthesis. * To assess the joint mobility function score 12 months after the reimplantation of the prosthesis. * To assess the safety of the combination of levofloxacin and rifampicin. * To investigate prognostic factors for success after the end of treatment and at 12 months after the reimplantation of the prosthesis.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00906048), actualizada en feb 2011.