Clinical Trial: Efficacy and Safety Study of Antibiotic Treatment to Treat Hip Prosthetic Joint Infection

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Prospective,Randomized,Open Label,European Multicenter Study of the Efficacy of the Linezolid-rifampin Combination Versus Standard of Care in the Treatment of Gram-positive.

Brief Summary: The purpose of this study is to evaluate the efficacy of oral linezolid-rifampin combination therapy (over 4 or 6 weeks) versus the standard of care in the treatment of Gram-positive prosthetic hip joint infection with a one-stage surgical treatment.

Detailed Summary:
Sponsor: University Hospital, Tours

Current Primary Outcome: Clinical cure rate [ Time Frame: 12 months after the end of treatment ]

Clinical cure rate in the modified intent-to-treat (mITT)population during the hospital visit. Patients will be declared cured if clinical signs of infection are normalized.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cure rate [ Time Frame: 12 months after the end of treatment ]
    Cure rate ine the modified intent-to-treat population during the hospital visit. Patients will be cdeclared cured if radiological and laboratory signs of infection are normalized.
  • Cure rate [ Time Frame: 6 and 24 months after the end of treatment for the modified intent-to-treat population and at 12 months for the per protocol population. ]
    Patients will be declared cured if clinical, radiological, and laboratory signs of infection normalized.


Original Secondary Outcome: Same as current

Information By: University Hospital, Tours

Dates:
Date Received: December 20, 2012
Date Started: October 2012
Date Completion: April 2016
Last Updated: May 27, 2014
Last Verified: May 2014