RECRUITING

Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-06-15

Study Completion:2027-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06409819

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Female kidney transplant recipients, aged 18 and older with a confirmed diagnosis of a history of recurring UTI with E. coli as their typical uropathogen. 2. Two urine culture proven UTIs in prior 6 months or three in prior 12 months due to E coli. UTI is defined as any change in symptoms from baseline urinary comfort (dysuria, hematuria, abdominal/flank pain, increased urinary frequency) or systemic signs of infection (fever, chills, systemic inflammatory reaction syndrome etc.) associated with a positive urine culture with bacterial growth of ≥104 colony forming units/mL). 3. Ability to self-administer study drug (or a family member that will do so) and willing to adhere to the phage therapy regimen. 4. For participants able to become pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 months after the end of phage therapy administration. 5. Provision of signed and dated informed consent form 6. Stated willingness to comply with all study procedures and availability for the duration of the study.	1. Presents with hardware in the urinary tract (e.g. stent, percutaneous nephrostomy, chronic urinary catheter). 2. Recipient of \>1 kidney transplant. 3. Recipient of Ileal conduit. 4. Recipient of surgical neobladder. 5. Diagnosed with chronic urinary retention requiring self-catheterization. 6. Anatomic cause for rUTI such as ureteral stenosis. 7. Within the first 3 months of kidney transplant. 8. Venous access sites or in whom an existing venous access site needs to be preserved for future need (as per the participant's transplant nephrologist/ surgeon) 9. Diagnosed with active cytomegalovirus or BK virus infections. 10. Current pregnancy, actively trying to conceive, or lactating. 11. Known allergic reactions to phage products. 12. Prisoners or individuals without decisional capacity.

Inclusion Criteria

Exclusion Criteria

1. Female kidney transplant recipients, aged 18 and older with a confirmed diagnosis of a history of recurring UTI with E. coli as their typical uropathogen.
2. Two urine culture proven UTIs in prior 6 months or three in prior 12 months due to E coli. UTI is defined as any change in symptoms from baseline urinary comfort (dysuria, hematuria, abdominal/flank pain, increased urinary frequency) or systemic signs of infection (fever, chills, systemic inflammatory reaction syndrome etc.) associated with a positive urine culture with bacterial growth of ≥104 colony forming units/mL).
3. Ability to self-administer study drug (or a family member that will do so) and willing to adhere to the phage therapy regimen.
4. For participants able to become pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 months after the end of phage therapy administration.
5. Provision of signed and dated informed consent form
6. Stated willingness to comply with all study procedures and availability for the duration of the study.

1. Presents with hardware in the urinary tract (e.g. stent, percutaneous nephrostomy, chronic urinary catheter).
2. Recipient of \>1 kidney transplant.
3. Recipient of Ileal conduit.
4. Recipient of surgical neobladder.
5. Diagnosed with chronic urinary retention requiring self-catheterization.
6. Anatomic cause for rUTI such as ureteral stenosis.
7. Within the first 3 months of kidney transplant.
8. Venous access sites or in whom an existing venous access site needs to be preserved for future need (as per the participant's transplant nephrologist/ surgeon)
9. Diagnosed with active cytomegalovirus or BK virus infections.
10. Current pregnancy, actively trying to conceive, or lactating.
11. Known allergic reactions to phage products.
12. Prisoners or individuals without decisional capacity.

Contacts and Locations

Study Contact

Saima Aslam, M.D.

CONTACT

(619) 543-3108

rUTIphagestudy@health.ucsd.edu

Study Locations (Sites)

University of California, San Diego

La Jolla, California, 92037

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-15

Study Completion Date2027-03-01

Study Record Updates

Study Start Date2025-06-15

Study Completion Date2027-03-01

Terms related to this study

Additional Relevant MeSH Terms

Urinary Tract Infection, Recurrent