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

Phase 3

Terminated

• Conditions: Infection
• Interventions: Drug: Levofloxacin (HR355) and Rifampicin Therapy

• 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

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-20
• Study First Submitted QC: 2009-05-20
• Study First Posted: 2009-05-21
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-04
• Last Update Posted: 2011-02-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

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