[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624287":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":77,"collaborators":26,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":26,"enrollmentInfo":91,"targetDuration":26,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":103,"whyStopped":26,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","ACTIVE_COMPARATOR","The intervention group (n=75) will receive pivmecillinam 400 mg once daily from months 1-6 post-transplantation",[13],"Drug: Pivmecillinam",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","PLACEBO_COMPARATOR","The control group (n=75) will receive placebo once daily from months 1-6 post-transplantation.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Pivmecillinam","The intervention group will receive pivmecillinam 400 mg once daily from months 1-6 post-transplantation.",[9],null,{"type":22,"name":28,"description":17,"armGroupLabels":29,"otherNames":26},"Placebo",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Susanne D Poulsen, MD, dr.med.","CONTACT","0045 3545 0859","susanne.dam.poulsen@regionh.dk",{"name":37,"role":33,"phone":38,"phoneExt":26,"email":39},"Dina L Møller, MD, Ph.d","0045 2066 3942","dina.leth.moeller@regionh.dk",[41,55,66],{"facility":42,"status":26,"city":43,"state":26,"zip":26,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Aarhus University Hospital","Aarhus","Denmark","DK",{"type":47,"coordinates":48},"Point",[49,50],10.21076,56.15674,{"lat":50,"lon":49},[53],{"name":54,"role":33,"phone":26,"phoneExt":26,"email":26},"Henrik Birn, MD, dr.med.",{"facility":56,"status":26,"city":57,"state":26,"zip":58,"country":44,"countryCode":45,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Rigshospitalet","Copenhagen","2100",{"type":47,"coordinates":60},[61,62],12.56553,55.67594,{"lat":62,"lon":61},[65],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},{"facility":67,"status":26,"city":68,"state":26,"zip":26,"country":44,"countryCode":45,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Odense University Hospital","Odense",{"type":47,"coordinates":70},[71,72],10.38831,55.39594,{"lat":72,"lon":71},[75],{"name":76,"role":33,"phone":26,"phoneExt":26,"email":26},"Claus Bistrup, MD, Ph.d.",{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Susanne Dam Nielsen, MD, DMSc","Professor, Chief Physician","100624287","phase-2-prediction-and-prevention-of-bloodstream-infections-after-kidney-transplantation-100624287",false,"NCT07407673","Prediction and Prevention of Bloodstream Infections After Kidney Transplantation","Prediction and Prevention of Bloodstream Infections After Kidney Transplantation - The PREDICT Study","PREDICT","Inclusion Criteria:\n\n* Adult (\\>18 years) KTx recipients at high risk of BSI in the first year post-KTx.\n\nRecipients at high risk of BSI will be defined as recipients belonging to a group with a predicted BSI incidence of 25% in the first year post-transplantation by the prediction model.\n\nExclusion Criteria:\n\n* Recipients who cannot give informed consent or have contraindications for pivmecillinam treatment, including allergy to beta-lactamase antibiotics.","ALL","18 Years",{"count":92,"type":93},150,"ESTIMATED","INTERVENTIONAL",[96],"PHASE2","Background: Kidney transplant (KTx) recipients receive life-long immunosuppression, which increases the risk of severe infections. Bloodstream infections (BSI) are common after transplantation and are associated with high mortality and morbidity. Prophylactic antibiotic treatment of all KTx recipients does not provide overall benefit, but a personalized strategy of prophylactic treatment of KTx recipients at high risk of BSI with targeted antibiotics has not been assessed.\n\nPrimary aim: To determine if prophylactic pivmecillinam in high-risk KTx recipients decreases the incidence of Enterobacterales BSI in the first 1-6 months post-transplantation.\n\nSecondary aim: To assess if prophylactic pivmecillinam reduces all-cause mortality, hospital admissions, graft loss, changes in the gut and urine resistome and microbiome, and increases quality of life in high-risk KTx recipients.\n\nDesign and target group: Multi-center double-blinded randomized controlled trial of 150 KTx recipients at high risk of BSI who will be randomized 1:1 to either pivmecillinam 400 mg once daily or placebo from months 1-6 post-transplantation. KTx recipients will be included from Rigshospitalet, Aarhus University Hospital and Odense University Hospital. 60 participants in each study arm will provide urine and stool samples at randomization and at the end of intervention for metagenomic sequencing of the bacterial microbiome and resistome.\n\nPerspectives: This trial will provide evidence necessary to assess if KTx recipients at high risk of BSI benefit from targeted prophylactic antibiotics and address a critical knowledge gap of how to reduce mortality and morbidity due to BSI after KTx. The study will also serve as proof-of-concept for a personalized approach to infection prevention in other populations at high risk of severe infections.\n\nResults from the study may easily be implemented since there is already a clinical set-up for prevention of viral infections in KTx recipients.",[99,100],"Kidney Transplant Infection","Bloodstream Infection",[102],"Prevention of bloodstream infection after kidney transplantation","NOT_YET_RECRUITING","2026-02-05",{"date":106,"type":107},"2026-02-12","ACTUAL",{"date":109,"type":93},"2027-01-01",{"date":111,"type":93},"2029-07",{"name":79,"class":6},3]