LEVOS - Levofloxacin and Rifampicin Therapy in the Treatment of OsteoArticular Prothethic Infection
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levofloxacin | Small molecule | 500 mg | Oral |
| Subject | Rifampin | Small molecule | 600 mg | Oral |
| Subject | Rifampin | Small molecule | 900 mg | Oral |