Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients
This study is looking at a new way to treat recurring urinary tract infections (UTIs) in women who have had a kidney transplant. It's testing a treatment called phage therapy, which uses special viruses (phages) that can kill specific bacteria like E. coli, a common cause of UTIs. Participants will receive either phage therapy, given intravenously (into a vein) twice a day for 7 days, or a placebo (sterile normal saline) given the same way. The main goals are to see if phage therapy is safe, how well people tolerate it, and if it's possible to run this type of study. Researchers also want to see if it might help reduce future UTIs. You may be able to join if you are a female kidney transplant recipient, aged 18 or older, and have a history of recurring UTIs caused by E. coli.
- Study design
- This is a randomized, placebo-controlled pilot study, meaning participants are randomly assigned to receive either phage therapy or a placebo, and neither you nor the researchers will know which you are receiving. The study plans to enroll 32 participants.
- What's involved
- Participants will receive intravenous treatment twice daily for 7 days. The study will assess your health and progress over 180 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 180 days after starting the study interventions to assess for adverse events and other outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0180 days
Safety of phage administration will be assessed by the incidence of adverse events (AE) as assessed by CTCAE v4.0. As this is a phase 1/ 2 pilot clinical study, the primary outcome is safety and tolerability of the IP.
- Enrollment Feasibility180 days
Enrollment feasibility of the trial protocol will be assessed by enrollment and randomization (goal is ≥75% of target N at year 1 of the award).
- Proportion of participants with a phage match180 days
Proportion of participants with a phage match will be assessed by the number of enrolled participants with a phage match (goal is ≥70%).
- Study Drug Adherence180 days
Adherence to study drug administration by the participants (goal is ≥90%),