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The Utility of Levofloxacin-Rifampin in the Therapy of Prosthetic Joint Infection

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00279864
Collaborator
Ortho-McNeil, Inc. (Industry)
15
Enrollment
1
Location
16
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prosthetic joint infection is a devastating complication of total joint arthroplasty ultimately leading to the failure of the total joint arthroplasty function and possibly death. Optimal treatment requires the resection of the infected total joint arthroplasty followed by prolonged parenteral antimicrobial therapy. This procedure is followed by reimplantation of a new total joint arthroplasty at a later date. Surgical debridement and retention of the infected total joint arthroplasty offers a more conservative surgical approach and has been proven to be cost-effective in selected groups of patients. Traditional medical therapy for staphylococcal infection would require an initial parenteral antimicrobial followed by chronic oral non-rifampin containing antimicrobial suppression regimen for the life of the total joint arthroplasty. With this strategy the success rate is close to 30%. Recently, several prospective studies of patients with THA, TKA and fracture fixation device infections conducted in Europe showed that the success rate with a 3-6 month course of a quinolone-rifampin combination is effective in 70% to 100% of cases. The proposed study will be a prospective open label observational cohort that will evaluate the outcome of Patients with S. aureus PJI treated with a medical regimen that includes oral levofloxacin- rifampin and debridement and retention of components. This medical regimen was approved for use by the Orthopedic Infectious Diseases focus group, Mayo Clinic, Rochester. 15 patients will be enrolled over a one-year period and followed up to minimum of 1 additional year. The outcome of this group will be compared to a historical group that is treated with traditional therapy.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    15 participants
    Time Perspective:
    Prospective
    Official Title:
    Prolonged Oral Levofloxacin-Rifampin for Staphylococcus Aureus Prosthetic Joint Infection (PJI) Treated With Debridement And Retention Of Components: A Prospective Observational Cohort Study. Mayo PJI Study Group (MPSG)*
    Study Start Date :
    Sep 1, 2005
    Actual Primary Completion Date :
    Jan 1, 2007
    Actual Study Completion Date :
    Jan 1, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No

      A maximum of 15 adult participants with total hip or total knee arthroplasty are approved for enrollment in this protocol at Mayo Clinic Rochester.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Mayo Clinic Rochester Minnesota United States 55905

      Sponsors and Collaborators

      • Mayo Clinic
      • Ortho-McNeil, Inc.

      Investigators

      • Principal Investigator: Elie F. Berbari, M.D., Mayo Clinic

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00279864
      Other Study ID Numbers:
      • 415-05
      • LEVO-BAC-4001
      First Posted:
      Jan 20, 2006
      Last Update Posted:
      Apr 30, 2015
      Last Verified:
      Apr 1, 2015
      Additional relevant MeSH terms:
      Infections
      Communicable Diseases
      Staphylococcal Infections
      Arthritis, Infectious

      Study Results

      No Results Posted as of Apr 30, 2015