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New treatment option for Urinary Tract Infection, Recurrent
Official title Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT06409819
What this study is testing
What is phage therapy?
phage therapy is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for urinary tract infection, recurrent.
Also referred to as targeted phage therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female kidney transplant recipients, aged 18 and older with a confirmed diagnosis of a history of recurring UTI with E. coli as their typical...
- 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...
- Ability to self-administer study drug (or a family member that will do so) and willing to adhere to the phage therapy regimen.
- 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...
- Provision of signed and dated informed consent form
You likely can't join if
- Presents with hardware in the urinary tract (e.g. stent, percutaneous nephrostomy, chronic urinary catheter).
- Recipient of \>1 kidney transplant.
- Recipient of Ileal conduit.
- Recipient of surgical neobladder.
- Diagnosed with chronic urinary retention requiring self-catheterization.
- Anatomic cause for rUTI such as ureteral stenosis.
See the full eligibility criteria
- 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.
- 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...
- Ability to self-administer study drug (or a family member that will do so) and willing to adhere to the phage therapy regimen.
- 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...
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Presents with hardware in the urinary tract (e.g. stent, percutaneous nephrostomy, chronic urinary catheter).
- Recipient of \>1 kidney transplant.
- Recipient of Ileal conduit.
- Recipient of surgical neobladder.
- Diagnosed with chronic urinary retention requiring self-catheterization.
- Anatomic cause for rUTI such as ureteral stenosis.
- Within the first 3 months of kidney transplant.
- 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)
- Diagnosed with active cytomegalovirus or BK virus infections.
- Current pregnancy, actively trying to conceive, or lactating.
- Known allergic reactions to phage products.
- Prisoners or individuals without decisional capacity.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.