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

NCT ID: NCT00279864

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-01-31

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.

Conditions

Staphylococcal Infection; Staphylococcus Aureus Prosthetic Joint Infection

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho-McNeil, Inc.

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Principal Investigators

Elie F. Berbari, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

LEVO-BAC-4001

Identifier Type: -

Identifier Source: secondary_id

415-05

Identifier Type: -

Identifier Source: org_study_id