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

NCT00906048 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2011-02-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Levofloxacin (HR355) and Rifampicin Therapy

Film-coated scored tablet measured at 500 mg of levofloxacin and capsule at 300 mg of rifampicin per os once a day Weight \< 70 kg: 1 tablet of levofloxacin and 2 capsules of rifampicin Weight \> 70 kg: 1 tablet of levofloxacin and 3 capsules of rifampicin

Sponsors & Collaborators

Principal Investigators

  • Nathalie Billon · sanofi-aventis administrative office

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00906048 on ClinicalTrials.gov