Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty
|ClinicalTrials.gov Identifier: NCT00423982|
Recruitment Status : Unknown
Verified June 2013 by Oslo University Hospital.
Recruitment status was: Active, not recruiting
First Posted : January 18, 2007
Last Update Posted : June 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Prosthesis-related Infections Staphylococcal Infections||Drug: Rifampin-combination therapy Drug: Monotherapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2014|
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.
- Cure defined as lack of clinical, biochemistry or radiological signs of infection at two years follow-up. [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|