[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infection-hip\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infection-hip":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100529302","phase-4-rifampicin-combination-therapy-versus-monotherapy-for-staphylococcal-prosthetic-joint-infection-100529302",false,"NCT06172010","Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infection","Rifampicin Combination Therapy Versus Targeted Antimicrobial Monotherapy in the Oral Antimicrobial Treatment Phase of Staphylococcal Prosthetic Joint Infection","RiCOTTA","Inclusion Criteria:\n\n* \\>18 years of age\n* Confirmed staphylococcal prosthetic hip or knee joint infection according to the current EBJIS 2021 definition of PJI\n* The causative agents are (or include) S. aureus or and\u002For Coagulase-negative staphylococci (CNS)\n* Treatment is according to the DAIR-procedure\n\nExclusion Criteria:\n\n(i) a contra-indication for rifampicin (e.g. a resistant strain or proven allergic reaction or difficult drug-drug-interactions) (ii) complicated S. aureus bacteremia or concurrent endocarditis requiring long-term iv antibiotic treatment \\> 2 weeks (iii) An infection for which there are no suitable antibiotic choices to permit Randomization between the two arms of the trial (for instance, where organisms are only sensitive to intravenous antibiotics) (iv) treatment failure before the start of oral therapy, (v) an unsatisfactory response to initial treatment leading to continuation of intravenous therapy beyond day 21, (vi) patients with an expected life expectancy \\\u003C12 months, (vii) patients with a tumor prosthesis (viii) patients receiving chemotherapy for active malignancy in the next 12 months (ix) patients who are scheduled in advance for chronic suppressive antibiotic therapy for \\>12 months, (x) The patient is unlikely to comply with trial requirements following Randomization in the opinion of the investigator (xi) Pregnancy (xii) Patients who are not able to read or communicate in Dutch or English will be excluded from participating in this study","ALL","18 Years",{"count":20,"type":21},316,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","In this Dutch multicenter clinical trial, patients with a staphylococcal prosthetic joint infection, will, in the oral antibiotic treatment phase, be randomized between clindamycin monotherapy and rifampicin \u002F levofloxacin combination therapy. The clinical endpoint will be treatment success one year after finishing antimicrobial treatment.",[27,28,29],"Prosthetic-joint Infection","Infection Hip","Infection; Knee, Joint",[31,32,33,34,35],"rifampicin","clindamycin","levofloxacin","prosthetic joint infection","antimicrobial treatment","RECRUITING","2023-12-06",{"date":39,"type":40},"2023-12-15","ACTUAL",{"date":42,"type":40},"2023-04-01",{"date":44,"type":21},"2028-03",{"name":46,"class":47},"Leiden University Medical Center","OTHER",13]