Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients
Phase 1/ 2 Trial of Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients
University of California, San Diego
32 participants
Jun 15, 2025
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
Plain Language Summary
Simplified for easier understanding
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
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.
Participants assigned to the control arm will start a 7-day course of intravenous sterile normal saline (placebo) administered twice daily.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06409819