LEVOS - Levofloxacin and Rifampicin Therapy in the Treatment of OsteoArticular Prothethic Infection
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.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Levofloxacin (HR355) and Rifampicin Therapy
Sanofi-Aventis Administrative Office
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00906048
- Information obtained from ClinicalTrials.gov on July 15, 2010
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