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Antibiotics for Kidney Transplant Recipients

NCT07106125 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-10-31

No results posted yet for this study

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

Conditions

  • Kidney Transplant
  • Urinary Tract Infection(UTI)
  • Antibiotic Prophylaxis
  • Remote Patient Monitoring
  • Feasibility Pilot Study

Interventions

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

DRUG

Trimethoprim-Sulfamethoxazole (TMP-SMX)

Kidney transplant recipients will continue to take TMP-SMX daily from months 6-12 after transplant

Sponsors & Collaborators

Principal Investigators

  • Alexandra Bicki, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2028-12-31
Completion
2029-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07106125 on ClinicalTrials.gov