Overview

This trial is active, not recruiting.

Conditions prosthesis-related infections, staphylococcal infections
Treatments rifampin-combination therapy, monotherapy
Phase phase 4
Sponsor Oslo University Hospital
Start date April 2006
End date December 2012
Trial size 100 participants
Trial identifier NCT00423982, 1603

Summary

The number of patients requiring joint replacement is increasing due to its success in restoring function and pain relief, and the growing population of the elderly. One of the most serious complications of arthroplasty is joint prosthesis infection. Due to the absence of prospective, randomized, controlled studies, there is no consensus concerning diagnosis and treatment of prosthetic joint infections. The main objective of this trial is to evaluate the clinical efficacy of rifampin combination therapy versus monotherapy using cloxacillin or vancomycin in early staphylococcal infections after total hip and knee arthroplasty.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Cloxacillin or vancomycin in combination with Rifampicin. Treatment of early staphylococcal prosthetic joint infections in addition to debridement and retention of the prosthesis.
rifampin-combination therapy Antimicrobial therapy in prosthetic joint infection.
Rifampin 300 mg x 3 po and cloxacillin 2 g x 4 iv for two weeks. Then rifampin 300 mg x 3 po and cloxacillin 1 g x 4 po for 4 weeks. In case of methicillin resistance, rifampin 300 mg x 3 po and vancomycin 1 g x 2 iv for 6 weeks.
(Active Comparator)
Cloxacillin or vancomycin in the treatment of early staphylococcal prosthetic joint infections in addition to debridement and retention of the prosthesis.
monotherapy Antimicrobial therapy in prosthetic joint infections.
Cloxacillin 2 g x 4 iv for two weeks, then cloxacillin 1 g x 4 po for 4 weeks. In case of methicillin resistance, vancomycin 1 g x 2 iv for 6 weeks.

Primary Outcomes

Measure
Cure defined as lack of clinical, biochemistry or radiological signs of infection at two years follow-up.
time frame: 2 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Prosthetic joint infections category 2 or 3 (early post.op infections within 4 weeks). - Diagnosis of staphylococci. - Clinically and radiographically stable implants kept in place after revision. Exclusion Criteria: - Infection with other microorganisms than staphylococci. - Less than 2 years of expected survival. - Predictable inability to comply with the treatment and/or follow-up visits. - Contraindication to the use of study medication including acute or chronic liver disease. - Lack of written consent. - Fertile women. - Patients taking less than 80% of the study medication.

Additional Information

Official title Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty
Description The study is a controlled randomized multicentre trial with 8 participating centres in Norway. We will include patients with the diagnosis of early infections (within 4 weeks post operatively)after hip or knee replacement. Patients with clinical signs of infection are scheduled for a standardized soft tissue revision. Diagnosis of staphylococci must be established by arthrocentesis or at surgical revision, and must grow in at least 2/8 cultures.The patients will randomly be assigned to antimicrobial therapy with or without rifampin by a randomization programme. Antibiotics will be given for 6 weeks. Two years follow-up. The study end points are final follow-up visit after two years or relapse of infection.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Oslo University Hospital.