Antibiotics for Kidney Transplant Recipients

Official title

Trial of Antibiotic Strategies for Kidney Transplant Recipients

Overview

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

• Drug Trimethoprim-Sulfamethoxazole (TMP-SMX)
  Kidney transplant recipients will continue to take TMP-SMX daily from months 6-12 after transplant
• Other Usual 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

Primary outcome measures

• Agreement Between Participant Self-Report and Medical Records on Clinical Events (Measured by Cohen's Kappa) [Time frame: From enrollment to the end of the study drug period (6 months)]
• Number of Participants Who Enroll After Screening [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 [Time frame: From enrollment to the end of the study drug period (6 months)]
• Trial Retention [Time frame: From enrollment to the end of the study drug period (6 months)]

Secondary outcome measures (4)

• Event Rate of All-Cause Hospitalizations by Treatment Arm [Time frame: From enrollment through the end of the study period (12 months)]
• Urinary Tract Infections by Treatment Arm [Time frame: From enrollment to the end of the study period (12 months)]
• Acute Kidney Injury Events by Treatment Arm [Time frame: From enrollment to the end of the study period (12 months)]
• Adverse Events by Treatment Arm [Time frame: From enrollment to the end of the study drug period (6 months)]

Eligibility criteria

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, (2) Diagnosis of neurogenic bladder and/or use of clean intermittent catheterization and/or nightly continuous urinary drainage, (3) Diabetes mellitus (diagnosed either prior to or new-onset after transplant), (4) History of recurrent UTIs as diagnosed by a provider prior to transplant, (5) Occurrence of any UTI in first 6 months after transplant, (6) Delayed graft function (defined as need for dialysis within 7 days of transplant)

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

United States · 1 center

• University of California, San Francisco — San Francisco

Identifiers

NCT: NCT07106125 · 25-44366

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗