Overview

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

Status:
Terminated
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Sanofi
Treatments:
Levofloxacin
Ofloxacin
Rifampin