Rifampin combination therapy versus monotherapy in early staphylococcal infections after total hip and knee arthroplasty

• Conditions: Joint prosthesis infection after total hip and knee arthroplasty.

• Registration Number: EUCTR2005-005494-29-NO
• Lead Sponsor: llevål University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

We will include patients with the diagnosis of prosthetic joint infections category 2 or 3 after total hip or knee replacement. Patients with clinical signs of infection (persisting local pain, erythema, warmth, wound healing disturbance, effusion and fever) with or without raised CRP, are scheduled for soft tissue revision. Diagnosis of staphylococci must be established by arthrocentesis or at surgical revision, and stapylococci must grow in at least 2/8 cultures. The infection must be diagnosed within 4 weeks of index operation or presumed debut of a hematogenous infection. The prosthesis must be stable and left in place after soft tissue revision. We will include patients from 10 different hospitals in Norway, and written informed consent will be required for all the study patients.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusions criteria will be: Infection with microorganisms other than staphylococci, less than 2 years of expected survival, predictable inability to comply with the treatment and/or follow-up, contraindications to the use of rifampin, cloxacillin or vancomycin, acute or chronic liver disease, lack of written consent, fertile women, patients taking less than 80% of the study medication, and antimicrobial therapy during the last 2 weeks before surgical revision.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified