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RECRUITING
NCT06409819
PHASE1/PHASE2

Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients

Sponsor: University of California, San Diego

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-06-15

Completion Date

2027-03-01

Last Updated

2025-08-14

Healthy Volunteers

No

Interventions

DRUG

phage 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.

DRUG

control

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