drugset / Trial / NCT06409819

Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients

NCT06409819 ↗

RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2025-06-15
Primary completion
2026-10-01
Completion
2027-03-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator phage therapy Other / unclassified 109 unknown Intravenous