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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
50
Kidney transplant recipients will continue to take TMP-SMX daily from months 6-12 after transplant
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
University of California, San Francisco
San Francisco, California, United States
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.
Time frame: From enrollment to the end of the study drug period (6 months)
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.
Time frame: Baseline/Study Day 1 (i.e., date that informed consent is signed for those who choose to participate)
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.
Time frame: From enrollment to the end of the study drug period (6 months)
Trial Retention
The investigators will keep track of how many participants complete the last study visit
Time frame: From enrollment to the end of the study drug period (6 months)
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.
Time frame: From enrollment through the end of the study period (12 months)
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.
Time frame: From enrollment to the end of the study period (12 months)
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.
Time frame: From enrollment to the end of the study period (12 months)
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
Time frame: From enrollment to the end of the study drug period (6 months)
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