Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|