RecruitingPhase 1Phase 2NCT06409819

Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients

Phase 1/ 2 Trial of Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients


Sponsor

University of California, San Diego

Enrollment

32 participants

Start Date

Jun 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This proposal will take an important first step in the study of phage therapy for treatment of recurrent urinary tract infection (rUTI) in female kidney transplant recipients (KTR); a common condition that is associated with increasing multidrug resistance, sickness, loss of kidney function and death. The investigators will conduct a randomized phase I/II pilot clinical trial of targeted phage therapy versus placebo in asymptomatic female KTR with a history of rUTI due to Escherichia coli to assess safety, tolerability, and feasibility of this approach, possible efficacy, and changes in the gut and urinary microbiome during the 180 days of the study. This highly innovative and impactful proposal will provide proof of concept data and also inform the design of a subsequent larger phase III clinical trial of phage therapy for rUTI treatment in KTR and will have broad downstream effects within the fields of infectious diseases and transplantation.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called control and a drug called phage therapy for people with urinary tract infection, recurrent. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGphage therapy

phage therapy will consist of a combination of three lytic phages that are active against the participant's E. coli isolates and will be administered intravenously twice daily for 7 days.

DRUGcontrol

Participants assigned to the control arm will start a 7-day course of intravenous sterile normal saline (placebo) administered twice daily.


Locations(1)

University of California, San Diego

La Jolla, California, United States

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NCT06409819