The Utility of Levofloxacin-Rifampin in the Therapy of Prosthetic Joint Infection
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)*
2 other identifiers
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 18, 2006
CompletedFirst Posted
Study publicly available on registry
January 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedApril 30, 2015
April 1, 2015
1.3 years
January 18, 2006
April 29, 2015
Conditions
Eligibility 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.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Mayo Cliniclead
- Ortho-McNeil, Inc.collaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elie F. Berbari, M.D.
Mayo Clinic
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 18, 2006
First Posted
January 20, 2006
Study Start
September 1, 2005
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
April 30, 2015
Record last verified: 2015-04