Actively Recruiting
Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients
Led by University of California, San Diego · Updated on 2025-08-14
32
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female kidney transplant recipients aged 18 and older with a history of recurrent UTI caused by E. coli
- At least two urine culture-confirmed UTIs in the prior 6 months or three in the prior 12 months due to E. coli
- Ability to self-administer the study drug or have a family member do so, and willingness to follow the therapy regimen
- For those who can become pregnant, use of highly effective contraception for at least 1 month before screening and agreement to continue during the study and for 6 months after therapy
- Signed and dated informed consent form provided
- Willingness to comply with study procedures and availability for the study duration
You will not qualify if you...
- Presence of hardware in the urinary tract such as stent, nephrostomy, or chronic catheter
- Recipient of more than one kidney transplant
- Recipient of ileal conduit or surgical neobladder
- Diagnosed with chronic urinary retention requiring self-catheterization
- Anatomic causes of recurrent UTI such as ureteral stenosis
- Within the first 3 months after kidney transplant
- Need to preserve venous access sites
- Active cytomegalovirus or BK virus infections
- Currently pregnant, trying to conceive, or breastfeeding
- Known allergies to phage products
- Prisoners or individuals without decisional capacity
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Diego
La Jolla, California, United States, 92037
Actively Recruiting
Research Team
S
Saima Aslam, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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