Antibiotics for Kidney Transplant Recipients

Официальное название

Trial of Antibiotic Strategies for Kidney Transplant Recipients

Обзор

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

Вмешательства

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

Первичные конечные точки

• Agreement Between Participant Self-Report and Medical Records on Clinical Events (Measured by Cohen's Kappa) [Срок оценки: From enrollment to the end of the study drug period (6 months)]
• Number of Participants Who Enroll After Screening [Срок оценки: Baseline/Study Day 1 (i.e., date that informed consent is signed for those who choose to participate)]
• Medication Adherence Assessed by Self-Report [Срок оценки: From enrollment to the end of the study drug period (6 months)]
• Trial Retention [Срок оценки: From enrollment to the end of the study drug period (6 months)]

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT07106125 · 25-44366

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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