Infection Clinical Trial
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.
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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