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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A National, Multicenter, Non-comparative Study Evaluating the Efficacy of the Combination of Levofloxacin (500 mg) and Rifampicin (600 or 900 mg Depending on Weight) Administered Once Daily by Oral Route, as Replacement of Empirical Antibiotic Therapy Given Intravenously With a Total Duration of 6 Weeks of the Antibiotic Therapy, in the Treatment of OsteoArticular Prosthetic Infections (OAPI), With a Two-stage Revision of the Prosthesis.|
- 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. [ Time Frame: During the reimplantation of the new prosthesis i.e. 15 days to 3 months after the end of treatment ] [ Designated as safety issue: No ]
- Clinical failure [ Time Frame: 12 months after reimplantation of the prosthesis ] [ Designated as safety issue: No ]
- Joint mobility function score [ Time Frame: 12 months after reimplantation of the prosthesis ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Levofloxacin and Rifampicin
Drug: Levofloxacin (HR355) and Rifampicin Therapy
Film-coated scored tablet measured at 500 mg of levofloxacin and capsule at 300 mg of rifampicin per os once a day
Weight < 70 kg: 1 tablet of levofloxacin and 2 capsules of rifampicin Weight > 70 kg: 1 tablet of levofloxacin and 3 capsules of rifampicin
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906048
|Sanofi-Aventis Administrative Office|
|Study Director:||Nathalie Billon||sanofi-aventis administrative office|