[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bacteriuria\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bacteriuria":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"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":36,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100624287","phase-3-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\n1. Age ≥18 years.\n2. Kidney transplant recipient.\n3. Able to provide written informed consent.\n4. ≥1 urine sample with bacteriuria ≥10\\^5 CFU\u002FmL (excluding fungi) within first month post-transplantation.\n\nExclusion Criteria:\n\n1. Known strictures in the esophagus and\u002For obstructions in the gastrointestinal tract including diabetes gastroparesis.\n2. Known hypersensitivity or allergy to β-lactam antibiotics.\n3. Known or suspected genetic metabolism anomalies in the carnitine metabolism, including carnitine transporter defect or organic acidurias such as methylmalonic aciduria or propionic acidaemia.\n4. Individuals of Faroese descent (defined as both biological parents born in the Faroe Islands).\n5. Porphyria.\n6. Current treatment with valproic acid, valproate or other medications liberating pivalic acid.\n7. Current treatment with probenecid.\n8. Current treatment with methotrexate.\n9. Ongoing dialysis one month post-transplantation.\n10. Pregnancy or breastfeeding.","ALL","18 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Kidney transplant recipients take medicines that suppress the immune system to prevent rejection of the transplanted kidney. As a result, they have a high risk of infections, especially urinary tract infections (UTIs). Some of these infections can spread to the bloodstream and cause serious illness, hospitalization, loss of kidney function, or death. Currently, there is no established strategy to prevent these serious bacterial infections in kidney transplant recipients who are at highest risk.\n\nThe PREDICT study is investigating whether a low daily dose of the antibiotic pivmecillinam can reduce the risk of bacterial urinary tract infections and bloodstream infections after kidney transplantation. The study focuses on kidney transplant recipients who have bacteria detected in their urine during the first month after transplantation, as previous research suggests that these patients have a particularly high risk of developing serious infections later.\n\nIn this randomized, double-blind, placebo-controlled trial, 180 adult kidney transplant recipients will be assigned by chance to receive either pivmecillinam or a matching placebo from 1 to 6 months after transplantation. Neither participants nor study staff will know which treatment has been assigned during the study. All participants will continue to receive standard post-transplant care and monitoring.\n\nThe main goal of the study is to determine whether prophylactic pivmecillinam can reduce the occurrence of infections caused by Enterobacterales bacteria, including urinary tract infections and bloodstream infections, during the first 6 months after transplantation. The study will also evaluate the effects of treatment on serious clinical outcomes, safety, quality of life, antimicrobial resistance, and long-term kidney transplant outcomes.\n\nThe study hypothesis is that targeted antibiotic prophylaxis with pivmecillinam in kidney transplant recipients at increased risk of infection will reduce the incidence of Enterobacterales urinary tract infections and bloodstream infections during the high-risk period after transplantation compared with placebo.",[27,28,29,30,31,32,33,34,35],"Kidney Transplant Infection","Bloodstream Infection","Kidney Transplant","Kidney Transplant Recipients","Infection","Urinary Tract Infection(UTI)","Urinary Tract Infection Bacterial","Antibiotic Prophylaxis","Bacteriuria",[37,38,39,40,41,42,43],"kidney transplantation","bloodstream infection","urinary tract infection","antibiotic prophylaxis","pivmecillinam","bacteriuria","Enterobacterales","NOT_YET_RECRUITING","2026-07-20",{"date":47,"type":48},"2026-07-22","ACTUAL",{"date":50,"type":21},"2027-01-01",{"date":52,"type":21},"2041-07",{"name":54,"class":55},"Susanne Dam Nielsen, MD, DMSc","OTHER",3,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":5},"100559091","phase-1-bacteriophage-therapy-in-spinal-cord-injury-patients-with-bacteriuria-100559091","NCT06559618","Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria","A Phase 1B Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria","Phage","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Adult (\\> age 18) with a diagnosis of Spinal Cord Injury\u002FDisease (SCI\u002FD) and neurogenic bladder. Eligible participants may include inpatients in the SCI care unit or outpatients receiving care at participating sites, regardless of the underlying cause of SCI (e.g., trauma, tumors or demyelinating).\n4. ASB with E. coli present in a quantity of ≥ 104 CFU\u002FmL.\n5. Require an indwelling (transurethral or suprapubic) or intermittent catheterization for bladder drainage.\n6. Women of childbearing potential and men with female partners of childbearing potential must use two forms of effective contraception during the study and for two weeks afterwards.\n7. Participant will be hospitalized during the 7 days of treatment or will be willing to attend clinic visits either (a) daily for the 7 days of treatment, or (b) on Day 1 and Day 7 of dosing. On Day 1, the participant will receive in-person training on instillation of the IP into the bladder.\n\nExclusion Criteria:\n\n1. Unable to provide informed consent for themselves.\n2. Received a new antibiotic expected to kill the Gram-negative organisms in the urine between initial enrollment urine culture and the time of randomization.\n3. History of neutropenia, defined by ANC \\\u003C 1000 per µL within 6 months prior to screening.\n4. History of organ transplantation.\n5. Presence of a surgically modified bladder, except for a repaired ruptured bladder.\n6. HIV with a CD4 count \\\u003C 200 cells per µL.\n7. Unstable vital signs (e.g., fever, hypotension)\n8. Symptoms of active urinary tract infection defined as fever, autonomic dysreflexia, generalized increase in spasticity, bladder spasms, new sweating, increase or change in lower abdominal pain, increase in burning or pain when passing urine, increase in burning or pain during catheterization, blood in the urine, or an increased sensation of urinary urgency (MedStar Health, Urinary Symptom Questionnaires for Neurogenic Bladder \\[USQNB\\]). The presence of any one of these symptoms, unless explained by a non-urinary or non-infectious condition, will be an exclusion criterion.\n9. Known urinary obstruction.\n10. Medical devices in the urinary tract (other than urinary catheters)\n11. Unless deemed acceptable by the sponsor-investigator, prescription drugs, OTC medications and supplements that acidify the urine are excluded.\n12. Stage 4 or greater chronic kidney disease\n13. Pregnant or breastfeeding female\n14. Three or more episodes of autonomic dysreflexia in prior 30 days; defined as those patients who have a SCI and who have had a documented sudden increase in systolic blood pressure of greater than 40 mmHg due to an irritation or stimulation (including bladder or bowel irritation) below the level of the SCI. Autonomic dysreflexia can include findings of hypertensive crisis or emergency, clinically significant bradycardia\u002Ftachycardia, severe headache or other severe reaction requiring an acute intervention. The sponsor-investigator will evaluate if a history of severe autonomic dysreflexia is suspected but not clearly identified.\n15. In the opinion of the sponsor-investigator, medical or psychiatric illness that would interfere with participation such as active, severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, or neurologic disease.",{"count":66,"type":21},30,[68],"PHASE1","This is a Phase 1b study to assess the safety, tolerability, PK, and PD of investigational phage therapy (IP) in adults with SCI and bladder colonization (ASB). It is a single-center, randomized, double-blind, placebo-controlled study in adults with SCI with neurogenic bladders and bacteriuria who use indwelling catheters, or who require intermittent catheterization for bladder drainage.",[35,71,72,73],"Spinal Cord Injuries","Asymptomatic Bacteriuria","Escherichia Coli",[75,35,76,77,78,79,80,81],"Bacteriophage","Phage Therapy","Spinal Cord Injury","Intravesicular infusion","Neurogenic Bladder","Intermittent catheterization","Randomized clinical trial","RECRUITING","2026-05-01",{"date":85,"type":48},"2026-05-05",{"date":87,"type":48},"2025-02-03",{"date":89,"type":21},"2028-12",{"name":91,"class":55},"Barbara Trautner"]