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
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/min/1.73 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/excessive neutropenia)
History of intolerance or allergy to trimethoprim (TMP) and/or 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 <1,000 cells/μL) on most recent bloodwork available at the time of recruitment
Uncontrolled hyperkalemia (serum potassium ≥5.0 mEq/L) on most recent bloodwork available at the time of recruitment
Parallel
Trimethoprim-Sulfamethoxazole (TMP-SMX)
DrugKidney transplant recipients will continue to take TMP-SMX daily from months 6-12 after transplant
Usual Care
Other interventionParticipants will take a placebo from months 6-12 after transplant and continue to receive all standard usual care related to their kidney transplant status
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.
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.
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.
Trial Retention
The investigators will keep track of how many participants complete the last study visit
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.
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.
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.
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
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This trial is not recruiting at the moment. You can still explore other options:
