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

This study has been completed.
Ortho-McNeil, Inc.
Information provided by:
Mayo Clinic Identifier:
First received: January 18, 2006
Last updated: April 29, 2015
Last verified: April 2015
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.

Staphylococcal Infection Staphylococcus Aureus Prosthetic Joint Infection

Study Type: Observational
Study Design: 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)*

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00279864

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Ortho-McNeil, Inc.
Principal Investigator: Elie F. Berbari, M.D. Mayo Clinic
  More Information Identifier: NCT00279864     History of Changes
Other Study ID Numbers: 415-05
Study First Received: January 18, 2006
Last Updated: April 29, 2015

Additional relevant MeSH terms:
Communicable Diseases
Staphylococcal Infections
Arthritis, Infectious
Gram-Positive Bacterial Infections
Bacterial Infections
Joint Diseases
Musculoskeletal Diseases
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on June 23, 2017