LEVOS - Levofloxacin and Rifampicin Therapy in the Treatment of OsteoArticular Prothethic Infection

2014-08-26 22:22:01 | BioPortfolio

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.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Infection

Intervention

Levofloxacin (HR355) and Rifampicin Therapy

Location

Sanofi-Aventis Administrative Office
Paris
France

Status

Terminated

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-26T22:22:01-0400

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