Trial of Antibiotic Strategies for Kidney Transplant Recipients
University of California, San Francisco
Summary
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
Eligibility
- Age range
- Up to 29 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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/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) * Considered "high risk for UTI" after kidney transplant, as defined by one or more of the following: (1) Congenital anomaly of kidney/urinary tract as kidney failure etiology…
Interventions
- DrugTrimethoprim-Sulfamethoxazole (TMP-SMX)
Kidney transplant recipients will continue to take TMP-SMX daily from months 6-12 after transplant
- OtherUsual 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
Location
- University of California, San FranciscoSan Francisco, California