[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07106125":3,"trial-entities:NCT07106125":125,"trial-summary:NCT07106125":130},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":49,"secondary_outcomes":64,"sex":79,"minimum_age":17,"maximum_age":80,"healthy_volunteers":15,"eligibility_criteria":81,"std_ages":98,"locations":101,"central_contacts":116,"overall_officials":119,"references":123,"see_also_links":124},"NCT07106125","25-44366","Antibiotics for Kidney Transplant Recipients","Trial of Antibiotic Strategies for Kidney Transplant Recipients","NOT_YET_RECRUITING","2029-01","2025-10","2025-10-31","2026-11","University of California, San Francisco","OTHER",false,"The goal of this clinical trial is to learn if a common antibiotic called trimethoprim-sulfamethoxazole (TMP-SMX) can help prevent urinary tract infections (UTIs) in children and young adults who recently had a kidney transplant. Most people take TMP-SMX for about 6 months after getting a kidney transplant. In this study, researchers want to see what happens if people keep taking it for 6 more months.\n\nThe main questions this study is asking are:\n\n* Does TMP-SMX lower the number of UTIs in the first year after transplant?\n* What side effects or problems do participants have while taking TMP-SMX?\n\nResearchers will compare TMP-SMX to a placebo (a look-alike pill that does not contain any medication) to see if TMP-SMX works to prevent UTIs.\n\nParticipants will:\n\n* Take either TMP-SMX or a placebo pill by mouth every day for 6 months\n* Have three visits to touch base with the study team about any issues\n* Complete short monthly online surveys about any symptoms or side effects\n* Share blood and urine test results from their regular transplant clinic visits",null,[19,20,21,22,23],"Kidney Transplant","Urinary Tract Infection(UTI)","Antibiotic Prophylaxis","Remote Patient Monitoring","Feasibility Pilot Study",[25,26,27,28,29],"kidney transplant","UTI prevention","antibiotic prophylaxis","decentralized trial","remote clinical trial","INTERVENTIONAL","PREVENTION",[33],"PHASE4",{"count":35,"type":36},50,"ESTIMATED",[38,44],{"type":39,"name":40,"description":41,"armGroupLabels":42},"DRUG","Trimethoprim-Sulfamethoxazole (TMP-SMX)","Kidney transplant recipients will continue to take TMP-SMX daily from months 6-12 after transplant",[43],"Drug",{"type":14,"name":45,"description":46,"armGroupLabels":47},"Usual Care","Participants will take a placebo from months 6-12 after transplant and continue to receive all standard usual care related to their kidney transplant status",[48],"Placebo",[50,54,58,61],{"measure":51,"description":52,"timeFrame":53},"Agreement Between Participant Self-Report and Medical Records on Clinical Events (Measured by Cohen's Kappa)","The investigators will look at how closely participants' self-reports of events (urinary tract and associated infections, acute kidney injury events, and hospitalizations) match what is identified through their electronic health records. To do this, the investigators will use a statistical tool called Cohen's kappa, which shows how much agreement there is between the two sources.","From enrollment to the end of the study drug period (6 months)",{"measure":55,"description":56,"timeFrame":57},"Number of Participants Who Enroll After Screening","The investigators will track how many people decide to join and how many people decline to join the study after completing the screening process.","Baseline\u002FStudy Day 1 (i.e., date that informed consent is signed for those who choose to participate)",{"measure":59,"description":60,"timeFrame":53},"Medication Adherence Assessed by Self-Report","The investigators will ask participants how often they are taking the pills as directed, through monthly surveys and at all study visits.",{"measure":62,"description":63,"timeFrame":53},"Trial Retention","The investigators will keep track of how many participants complete the last study visit",[65,69,73,76],{"measure":66,"description":67,"timeFrame":68},"Event Rate of All-Cause Hospitalizations by Treatment Arm","The investigators will keep track of when participants are hospitalized, using feedback from participants themselves (for the first 6 months) as well as data from their electronic medical records (for 6 additional months, for a total of 12 months). Event rates will be used to compare outcomes between the treatment (TMP-SMX continuation) and placebo arms.","From enrollment through the end of the study period (12 months)",{"measure":70,"description":71,"timeFrame":72},"Urinary Tract Infections by Treatment Arm","The investigators will keep track of when participants report having a urinary tract infection, using feedback from participants themselves (for the first 6 months) as well as data from their electronic medical records (for 6 additional months, for a total of 12 months). Event rates will be used to compare outcomes between the treatment (TMP-SMX continuation) and placebo arms.","From enrollment to the end of the study period (12 months)",{"measure":74,"description":75,"timeFrame":72},"Acute Kidney Injury Events by Treatment Arm","The investigators will keep track of when participants report having acute kidney injury events, using feedback from participants themselves (for the first 6 months) as well as data from their electronic medical records (for 6 additional months, for a total of 12 months). Event rates will be used to compare outcomes between the treatment (TMP-SMX continuation) and placebo arms.",{"measure":77,"description":78,"timeFrame":53},"Adverse Events by Treatment Arm","The investigators will keep track of when participants report side effects and adverse events, using feedback from participants themselves as well as data from their electronic medical records","ALL","29 Years",{"inclusion":82,"exclusion":88,"raw_text":97},[83,84,85,86,87],"Must be able to take capsules orally","Kidney transplant performed at a UCSF facility within the last 6 months","Most recent glomerular filtration rate (GFR) \\>30 mL\u002Fmin\u002F1.73 m2","Tolerated initial 6 months of post-transplant TMP-SMX (defined as no intentional periods of TMP-SMX cessation in first 6 months after transplant due to hyperkalemia, allergic reaction, or unexpected\u002Fexcessive neutropenia)","Considered \"high risk for UTI\" after kidney transplant, as defined by one or more of the following: (1) Congenital anomaly of kidney\u002Furinary tract as kidney failure etiology, (2) Diagnosis of neurogenic bladder and\u002For use of clean intermittent catheterization and\u002For nightly continuous urinary drainage, (3) Diabetes mellitus (diagnosed either prior to or new-onset after transplant), (4) History of recurrent UTIs as diagnosed by a provider prior to transplant, (5) Occurrence of any UTI in first 6 months after transplant, (6) Delayed graft function (defined as need for dialysis within 7 days of transplant)",[89,90,91,92,93,94,95,96],"History of intolerance or allergy to trimethoprim (TMP) and\u002For sulfamethoxazole (SMX)","History of UTI due to a TMP-SMX-resistant organism in the first 6 months after transplant","Moderate or severe neutropenia (absolute neutrophil count \\\u003C1,000 cells\u002FμL) on most recent bloodwork available at the time of recruitment","Uncontrolled hyperkalemia (serum potassium ≥5.0 mEq\u002FL) on most recent bloodwork available at the time of recruitment","Provider-determined\u002Fdocumented need for either continuation or discontinuation of TMP-SMX prophylaxis that would preclude the patient's randomization","Current pregnancy","Incarcerated individuals\u002Fprisoners","Inability to provide informed consent or assent, and no legally authorized representative available","Inclusion Criteria:\n\n* Must be able to take capsules orally\n* Kidney transplant performed at a UCSF facility within the last 6 months\n* Most recent glomerular filtration rate (GFR) \\>30 mL\u002Fmin\u002F1.73 m2\n* Tolerated initial 6 months of post-transplant TMP-SMX (defined as no intentional periods of TMP-SMX cessation in first 6 months after transplant due to hyperkalemia, allergic reaction, or unexpected\u002Fexcessive neutropenia)\n* Considered \"high risk for UTI\" after kidney transplant, as defined by one or more of the following: (1) Congenital anomaly of kidney\u002Furinary tract as kidney failure etiology, (2) Diagnosis of neurogenic bladder and\u002For use of clean intermittent catheterization and\u002For nightly continuous urinary drainage, (3) Diabetes mellitus (diagnosed either prior to or new-onset after transplant), (4) History of recurrent UTIs as diagnosed by a provider prior to transplant, (5) Occurrence of any UTI in first 6 months after transplant, (6) Delayed graft function (defined as need for dialysis within 7 days of transplant)\n\nExclusion Criteria:\n\n* History of intolerance or allergy to trimethoprim (TMP) and\u002For sulfamethoxazole (SMX)\n* History of UTI due to a TMP-SMX-resistant organism in the first 6 months after transplant\n* Moderate or severe neutropenia (absolute neutrophil count \\\u003C1,000 cells\u002FμL) on most recent bloodwork available at the time of recruitment\n* Uncontrolled hyperkalemia (serum potassium ≥5.0 mEq\u002FL) on most recent bloodwork available at the time of recruitment\n* Provider-determined\u002Fdocumented need for either continuation or discontinuation of TMP-SMX prophylaxis that would preclude the patient's randomization\n* Current pregnancy\n* Incarcerated individuals\u002Fprisoners\n* Inability to provide informed consent or assent, and no legally authorized representative available",[99,100],"CHILD","ADULT",[102],{"facility":13,"city":103,"state":104,"zip":105,"country":106,"contacts":107,"geoPoint":113},"San Francisco","California","94158","United States",[108],{"name":109,"role":110,"phone":111,"email":112},"Principal Investigator","CONTACT","415-476-3548","alexandra.bicki@uscf.edu",{"lat":114,"lon":115},37.77493,-122.41942,[117],{"name":109,"role":110,"phone":111,"email":118},"alexandra.bicki@ucsf.edu",[120],{"name":121,"affiliation":13,"role":122},"Alexandra Bicki, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":126,"biomarkers":129},[127,128],"Kidney Transplantation","Urinary Tract Infection",[],{"nct_id":4,"found":131,"summary":132,"prompt_version":141},true,{"design":133,"status":134,"heading":6,"summary":135,"follow_up":136,"word_count":137,"commitments":138,"compensation":139,"drugs_mentioned":140},"This is an interventional study with a planned enrollment of 50 participants. It compares taking TMP-SMX to taking a placebo.","completed","This study is looking at whether the antibiotic trimethoprim-sulfamethoxazole (TMP-SMX) can help prevent urinary tract infections (UTIs) in children and young adults who have recently had a kidney transplant. Typically, people take TMP-SMX for 6 months after a transplant. This study will compare taking TMP-SMX for an additional 6 months to taking a placebo (an inactive pill) to see if it reduces UTIs and what side effects might occur. You may be able to join if you are under 29 years old, had a kidney transplant at a UCSF facility within the last 6 months, and meet certain health criteria, including a specific kidney function (GFR >30 mL\u002Fmin\u002F1.73 m2). The study aims to see how well participants report their health events and how consistently they take their medication.","Participants will be followed from enrollment until the end of the study drug period, which is 6 months.",128,"Participants will take either TMP-SMX or a placebo daily for 6 months, from 6 to 12 months after their transplant. They will also continue to receive standard care for their kidney transplant.","Not stated in the trial record.",[40],"v2"]