Antibiotic Prophylaxis, Feasibility Pilot Study, Kidney Transplant, Remote Patient Monitoring, Urinary Tract Infection(UTI)
Conditions
Keywords
kidney transplant, UTI prevention, antibiotic prophylaxis, decentralized trial, remote clinical trial
Brief 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
Interventions
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
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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 * Provider-determined/documented need for either continuation or discontinuation of TMP-SMX prophylaxis that would preclude the patient's randomization * Current pregnancy * Incarcerated individuals/prisoners * Inability to provide informed consent or assent, and no legally authorized representative available
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event Rate of All-Cause Hospitalizations by Treatment Arm | From enrollment through the end of the study period (12 months) | 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 | From enrollment to the end of the study period (12 months) | 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 | From enrollment to the end of the study period (12 months) | 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 | From enrollment to the end of the study drug period (6 months) | 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 |
Countries
United States
Contacts
CONTACTPrincipal Investigator
PRINCIPAL_INVESTIGATORAlexandra Bicki, MD
University of California, San Francisco
Outcome results
None listed