Trial of Antibiotic Strategies for Kidney Transplant Recipients (TASK)

NCT07106125 Phase 4 NOT_YET_RECRUITING

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. The main questions this study is asking are: * Does TMP-SMX lower the number of UTIs in the first year after transplant? * What side effects or problems do participants have while taking TMP-SMX? Researchers 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. Participants will: * Take either TMP-SMX or a placebo pill by mouth every day for 6 months * Have three visits to touch base with the study team about any issues * Complete short monthly online surveys about any symptoms or side effects * Share blood and urine test results from their regular transplant clinic visits

Details

Lead sponsor	University of California, San Francisco
Phase	Phase 4
Status	NOT_YET_RECRUITING
Enrolment	50
Start date	2026-11
Completion	2029-01

Conditions

• Kidney Transplant
• Urinary Tract Infection(UTI)
• Antibiotic Prophylaxis
• Remote Patient Monitoring
• Feasibility Pilot Study

Interventions

• Trimethoprim-Sulfamethoxazole (TMP-SMX)
• Usual Care

Primary outcomes

• Agreement Between Participant Self-Report and Medical Records on Clinical Events (Measured by Cohen's Kappa) — From enrollment to the end of the study drug period (6 months)
  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.
• Number of Participants Who Enroll After Screening — Baseline/Study Day 1 (i.e., date that informed consent is signed for those who choose to participate)
  The investigators will track how many people decide to join and how many people decline to join the study after completing the screening process.
• Medication Adherence Assessed by Self-Report — From enrollment to the end of the study drug period (6 months)
  The investigators will ask participants how often they are taking the pills as directed, through monthly surveys and at all study visits.
• Trial Retention — From enrollment to the end of the study drug period (6 months)
  The investigators will keep track of how many participants complete the last study visit

Countries

United States