LEVOS - Levofloxacin and Rifampicin Therapy in the Treatment of OsteoArticular Prothethic Infection
- Registration Number
- NCT00906048
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Levofloxacin (HR355) and Rifampicin Therapy Levofloxacin and Rifampicin
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Clinical failure 12 months after reimplantation of the prosthesis Joint mobility function score 12 months after reimplantation of the prosthesis
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇫🇷Paris, France