[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570588":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":65,"centralContacts":69,"locations":75,"responsibleParty":140,"collaborators":34,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":144,"sex":150,"minAge":151,"maxAge":34,"enrollmentInfo":152,"targetDuration":34,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":165,"overallStatus":106,"whyStopped":34,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Targeted antimicrobial prophylaxis","EXPERIMENTAL","The participants in this arm will receive a single-day orally administered targeted antimicrobial prophylaxis on the day of ureteral stent removal based on the microbiological analysis of a postoperative urine culture.",[13,14,15,16,17,18,19,20,21,22],"Drug: Pivmecillinam","Drug: Amoxicillin clavulanic acid","Drug: Amoxicillin","Drug: Cefuroxime","Drug: Ciprofloxacin","Drug: Linezolid","Drug: Nitrofurantoin","Drug: Trimethoprim","Drug: Sulfamethoxazole trimethoprim","Drug: Fluconazole",{"label":24,"type":25,"description":26,"interventionNames":27},"Empiric antimicrobial prophylaxis","ACTIVE_COMPARATOR","The participants in this arm will receive three doses of orally administered pivmecillinam 400mg morning, noon, and evening on the day of ureteral stent removal.",[13],[29,35,38,41,44,47,50,53,56,59,62],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Pivmecillinam","Orally administered pivmecillinam 400mg",[24],null,{"type":30,"name":31,"description":36,"armGroupLabels":37,"otherNames":34},"Orally administered targeted antimicrobial prophylaxis based on a urine culture.",[9],{"type":30,"name":39,"description":36,"armGroupLabels":40,"otherNames":34},"Amoxicillin clavulanic acid",[9],{"type":30,"name":42,"description":36,"armGroupLabels":43,"otherNames":34},"Amoxicillin",[9],{"type":30,"name":45,"description":36,"armGroupLabels":46,"otherNames":34},"Cefuroxime",[9],{"type":30,"name":48,"description":36,"armGroupLabels":49,"otherNames":34},"Ciprofloxacin",[9],{"type":30,"name":51,"description":36,"armGroupLabels":52,"otherNames":34},"Linezolid",[9],{"type":30,"name":54,"description":36,"armGroupLabels":55,"otherNames":34},"Nitrofurantoin",[9],{"type":30,"name":57,"description":36,"armGroupLabels":58,"otherNames":34},"Trimethoprim",[9],{"type":30,"name":60,"description":36,"armGroupLabels":61,"otherNames":34},"Sulfamethoxazole trimethoprim",[9],{"type":30,"name":63,"description":36,"armGroupLabels":64,"otherNames":34},"Fluconazole",[9],[66],{"name":67,"affiliation":5,"role":68},"Andreas Røder, Prof, MD, PhD","PRINCIPAL_INVESTIGATOR",[70],{"name":71,"role":72,"phone":73,"phoneExt":34,"email":74},"Maja Vejlgaard","CONTACT","+4535456152","maja.vejlgaard.02@regionh.dk",[76,92,104,116,128],{"facility":77,"status":78,"city":79,"state":34,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Department of Urology, Aalborg University Hospital","NOT_YET_RECRUITING","Aalborg","9100","Denmark","DK",{"type":84,"coordinates":85},"Point",[86,87],9.9187,57.048,{"lat":87,"lon":86},[90],{"name":91,"role":72,"phone":34,"phoneExt":34,"email":34},"Knud Fabrin, MD",{"facility":93,"status":78,"city":94,"state":34,"zip":95,"country":81,"countryCode":82,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Department of Urology, Aarhus University Hospital","Aarhus","8200",{"type":84,"coordinates":97},[98,99],10.21076,56.15674,{"lat":99,"lon":98},[102],{"name":103,"role":72,"phone":34,"phoneExt":34,"email":34},"Jørgen Bjerggaard Jensen, Prof, MD, PhD",{"facility":105,"status":106,"city":107,"state":34,"zip":108,"country":81,"countryCode":82,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Department of Urology, Rigshospitalet","RECRUITING","Copenhagen","2100",{"type":84,"coordinates":110},[111,112],12.56553,55.67594,{"lat":112,"lon":111},[115],{"name":67,"role":72,"phone":34,"phoneExt":34,"email":34},{"facility":117,"status":78,"city":118,"state":34,"zip":119,"country":81,"countryCode":82,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Department of Urology, Herlev and Gentofte Hospital","Herlev","2730",{"type":84,"coordinates":121},[122,123],12.43998,55.72366,{"lat":123,"lon":122},[126],{"name":127,"role":72,"phone":34,"phoneExt":34,"email":34},"Gitte Lam, MD",{"facility":129,"status":78,"city":130,"state":34,"zip":131,"country":81,"countryCode":82,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Department of Urology, Odense University Hospital","Odense","5000",{"type":84,"coordinates":133},[134,135],10.38831,55.39594,{"lat":135,"lon":134},[138],{"name":139,"role":72,"phone":34,"phoneExt":34,"email":34},"Lars Lund, Prof, MD, DMSci",{"type":68,"investigatorFullName":71,"investigatorTitle":141,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Coordinating investigator, MD","100570588","phase-4-clinical-trial-testing-whether-targeted-antibiotic-prophylaxis-can-reduce-infections-after-cystectomy-compared-to-empiric-prophylaxis-100570588",false,"NCT06709196","Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis","REINFORCE - Reducing Infection-related Readmissions Following Cystectomy. a Multicentre Randomised Clinical Trial Testing Superiority of Individualised Targeted Antibiotic Prophylaxis Over Empiric Prophylaxis At Ureteral Stent Removal to Reduce Infection-related Readmissions Following Cystectomy.","REINFORCE","Inclusion Criteria:\n\n* Age at surgery ≥ 18 years\n* Ability to understand and sign an informed consent\n* Malignant or benign indication for undergoing cystectomy\n* Planned ileal conduit as urinary diversion\n\nExclusion Criteria:\n\n* Previous severe allergic reaction to antimicrobial treatment\n* Long-term prophylactic antibiotic treatment which is expected to be continued after the cystectomy","ALL","18 Years",{"count":153,"type":154},248,"ESTIMATED","INTERVENTIONAL",[157],"PHASE4","The aim of this trial is to test whether postoperative antibiotics targeted towards bacteria in the urine can reduce the risk of infection after surgical removal of the bladder (cystectomy) compared to a standardised antibiotic prophylaxis.\n\nParticipants undergoing cystectomy will be randomly assigned to postoperatively receive (A) a standardised orally administered antibiotic prophylaxis currently given at Rigshospitalet, Copenhagen or (B) a conventional orally administered antibiotic prophylaxis targeting bacteria found in the urine postoperatively.\n\nThe investigators' hypothesis is that the targeted prophylactic antibiotic strategy will reduce the number of infection-related readmissions within 90 days of surgery compared to the standardised prophylaxis.",[160,161,162,163,164],"Cystectomy","Bladder Cancer Requiring Cystectomy","Postoperative Infections","Antibiotic Prophylaxis","Ileal Conduit",[9,166],"Infection-related readmissions","2025-01-08",{"date":169,"type":170},"2025-01-09","ACTUAL",{"date":172,"type":170},"2025-01-07",{"date":174,"type":154},"2027-01",{"name":5,"class":6},5]