Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty
Recruitment status was Active, not recruiting
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.
Drug: Rifampin-combination therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty|
- Cure defined as lack of clinical, biochemistry or radiological signs of infection at two years follow-up. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Rifampicin-combination therapy
Cloxacillin or vancomycin in combination with Rifampicin. Treatment of early staphylococcal prosthetic joint infections in addition to debridement and retention of the prosthesis.
Drug: Rifampin-combination therapy
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: Monotherapy
Cloxacillin or vancomycin in the treatment of early staphylococcal prosthetic joint infections in addition to debridement and retention of the prosthesis.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423982
|Buskerud Central Hospital|
|Drammen, Norway, 3004|
|Elverum, Norway, 2408|
|Martina Hansen Hospital|
|Gjettum, Norway, 1346|
|Hønefoss, Norway, 3504|
|Lillehammer, Norway, 2609|
|Oslo University Hospital, Ulleval|
|Oslo, Norway, 0407|
|Asker and Bærum Hospital|
|Rud, Norway, 1309|
|Trondheim, Norway, 7030|
|Study Director:||Finnur Snorrason, M.D, Ph.D||Ullevaal University Hospital|