drugset / Trial / NCT00906048

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

NCT00906048

Phase 3 Terminated 10 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The 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.

Timeline

Start
2009-04
Primary completion
2010-04
Completion
2010-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Levofloxacin Small molecule 500 mg Oral
Subject Rifampin Small molecule 600 mg Oral
Subject Rifampin Small molecule 900 mg Oral

Indications