Recruiting
Phase 1
Phase 2

Phage Therapy

Sponsor:

UCLA

Code:

NCT06409819

Conditions

Urinary Tract Infection, Recurrent

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

phage therapy

control

Study Details

Brief summary:

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

Urinary Tract Infection, Recurrent

Study ID

NCT06409819

Start date

Jun 15, 2025

Status verified date

Aug, 2025

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Intervention phage therapy

Clear 1 milliliter (ml) solution in a plastic needless syringe. Phage therapy will consist of twice daily intravenous (IV) dose of previously selected phage combination of at least 109 plaque forming units (PFU)/ ml concentration per phage but not to exceed 5EU/Kg/hr of total lipopolysaccharide endotoxin for the entire dose as per FDA guidelines.

placebo comparator: Intervention control arm (normal saline placebo)

Clear 1mL solution in a plastic needless syringe. Placebo will consist of IV normal saline administered in the same manner as the active comparator for 7 days.

Interventions

phage therapy

phage therapy will consist of a combination of three lytic phages that are active against the participant's E. coli isolates and will be administered intravenously twice daily for 7 days.

control

Participants assigned to the control arm will start a 7-day course of intravenous sterile normal saline (placebo) administered twice daily.

Primary outcome measure

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 180 days ]
  • Enrollment Feasibility [ Time Frame: 180 days ]
  • Proportion of participants with a phage match [ Time Frame: 180 days ]
  • Study Drug Adherence [ Time Frame: 180 days ]

Central Contacts and Locations

Central contacts

Saima Aslam, M.D.

(619) 543-3108rUTIphagestudy@health.ucsd.edu

Locations

University of California, San Diego

Recruiting

La Jolla, California, United States, 92037

Contacts

Saima Aslam, MD

8586577643saslam@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Aug 14, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-08-14.