Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · May 7, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called phage therapy for female kidney transplant recipients who suffer from recurrent urinary tract infections (rUTIs). These infections, often caused by bacteria like E. coli and Klebsiella pneumoniae, can be challenging to treat, especially due to growing resistance to many antibiotics. The researchers want to find out if phage therapy is safe and effective for these patients, and they will be comparing it to a placebo (a treatment that has no active ingredients) over a period of 180 days. The study also aims to understand how this therapy might change the bacteria in the gut and urinary tract.

To be eligible for the trial, participants must be female kidney transplant recipients aged 18 or older with a history of recurrent UTIs caused by the specified bacteria. This means they should have had at least two infections in the past six months or three in the last year. Participants need to be able to follow the treatment plan and may need to use effective birth control if they could become pregnant. Those with certain medical conditions, recent surgeries, or specific infections will not be able to participate. If you join the study, you'll receive close monitoring and guidance throughout the process, and your involvement will contribute to important research that could help improve treatment options for kidney transplant recipients in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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.