[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588532":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":35,"responsibleParty":57,"collaborators":59,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":19,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":19,"enrollmentInfo":73,"targetDuration":19,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":19,"overallStatus":83,"whyStopped":19,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":74},{"fullName":5,"class":6},"Orthopaedic Innovation Centre","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Phage Therapy","EXPERIMENTAL","Lytic phage prepared in injection-grade saline-magnesium buffer will be given via two routes: a) intravenously twice daily, and concomitantly, b) intra-articularly twice daily, for a total duration of 14 days. In addition to phage therapy, the patient will receive standard of care antibiotic therapy.",[13],"Biological: Phage Therapy",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Our phage is an investigational treatment for bacterial infections. Our lytic phage preparation was provided by Cytophage Technologies (CIP-200).",[9],null,[21],{"name":22,"affiliation":23,"role":24},"David Hedden, MD","Concordia Hospital","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Sarah Tran","CONTACT","204-926-1231","stran@orthoinno.com",{"name":32,"role":28,"phone":33,"phoneExt":19,"email":34},"Christiaan Righolt, PhD","204-926-1224","crigholt@orthoinno.com",[36],{"facility":23,"status":19,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Winnipeg","Manitoba","R2K 3S8","Canada","CA",{"type":43,"coordinates":44},"Point",[45,46],-97.14704,49.8844,{"lat":46,"lon":45},[49,50,54],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},{"name":51,"role":28,"phone":52,"phoneExt":19,"email":53},"Trevor Gascoyne","204-926-1235","tgascoyne@orthoinno.com",{"name":55,"role":56,"phone":19,"phoneExt":19,"email":19},"David Hedden, MD FRCSC","SUB_INVESTIGATOR",{"type":58,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[60,63],{"name":61,"class":62},"Cytophage Technologies Inc.","UNKNOWN",{"name":64,"class":6},"Ottawa Hospital Research Institute","100588532","phase-1-phage-therapy-for-the-treatment-of-a-chronic-enterococcus-faecium-periprosthetic-joint-infection-100588532",false,"NCT06942624","Phage Therapy for the Treatment of a Chronic Enterococcus Faecium Periprosthetic Joint Infection","Inclusion Criteria:\n\nThis N-of-1 Phage therapy is designed for one patient who meet the following conditions\n\n* Willingness to provide signed and dated informed consent form to participate in the clinical study\n* Chronic prosthetic joint infection\n* History of multiple surgical and medication managements with no success\n\nExclusion Criteria:\n\n* below 18 years of age","MALE","18 Years",{"count":74,"type":75},1,"ESTIMATED","INTERVENTIONAL",[78,79],"PHASE1","PHASE2","This purpose of this clinical trial is to evaluate the safety, tolerability and efficacy of a bacteriophage therapy in a patient with a methicillin-susceptible Enterococcus faecium (E. faecium) prosthetic joint infection (PJI) of the hip. We have exhausted all surgical and medical management of PJI for our patient.\n\nThe phage will be administered to the study patient during a 14 days period via intravenous and intra-articular. The patient will be monitored in clinic for up to 1 year.",[82],"Periprosthetic Joint Infection","NOT_YET_RECRUITING","2025-04-17",{"date":86,"type":87},"2025-04-24","ACTUAL",{"date":89,"type":75},"2025-05",{"date":91,"type":75},"2026-06",{"name":5,"class":6}]