Trial of Antibiotic Strategies for Kidney Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Agreement Between Participant Self-Report and Medical Records on Clinical Events (Measured by Cohen's Kappa)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Drug
TMP-SMX
干预措施: Trimethoprim-Sulfamethoxazole (TMP-SMX) (Drug)
Placebo
Placebo
干预措施: Usual Care (Other)
结局指标
主要结局
Agreement Between Participant Self-Report and Medical Records on Clinical Events (Measured by Cohen's Kappa)
时间窗: 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
时间窗: 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.
Trial Retention
时间窗: 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
Agreement Between Participant Self-Report and Medical Records on Clinical Events (Measured by Cohen's Kappa)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Adverse Events by Treatment Arm(From enrollment to the end of the study drug period (6 months))
- Urinary Tract Infections by Treatment Arm(From enrollment to the end of the study period (12 months))
- Acute Kidney Injury Events by Treatment Arm(From enrollment to the end of the study period (12 months))
- Event Rate of All-Cause Hospitalizations by Treatment Arm(From enrollment through the end of the study period (12 months))
- Event Rate of All-Cause Hospitalizations by Treatment Arm(From enrollment through the end of the study period (12 months))
- Urinary Tract Infections by Treatment Arm(From enrollment to the end of the study period (12 months))
- Acute Kidney Injury Events by Treatment Arm(From enrollment to the end of the study period (12 months))
- Adverse Events by Treatment Arm(From enrollment to the end of the study drug period (6 months))