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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
Ortho-McNeil, Inc. |
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00279864 |
Purpose
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 |
|---|
|
Staphylococcal Infection Staphylococcus Aureus Prosthetic Joint Infection |
| Study Type: | Observational |
| Study Design: | 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)* |
| Enrollment: | 15 |
| Study Start Date: | September 2005 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
A maximum of 15 adult participants with total hip or total knee arthroplasty are approved for enrollment in this protocol at Mayo Clinic Rochester.
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
More Information
| Study ID Numbers: | 415-05, LEVO-BAC-4001 |
| Study First Received: | January 18, 2006 |
| Last Updated: | February 1, 2010 |
| ClinicalTrials.gov Identifier: | NCT00279864 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Bacterial Infections Communicable Diseases Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Joint Diseases Ofloxacin Anti-Infective Agents, Urinary Enzyme Inhibitors Arthritis, Infectious Renal Agents |
Infection Pharmacologic Actions Staphylococcal Infections Anti-Bacterial Agents Gram-Positive Bacterial Infections Musculoskeletal Diseases Arthritis Therapeutic Uses Nucleic Acid Synthesis Inhibitors |