Bacteriophage Therapy in Patients With Urinary Tract Infections

A Phase I/II Study of Bacteriophage Therapy to Evaluate Safety, Tolerability, and Efficacy of Targeted Personalized Bacteriophage Treatments in Patients With Bacterial Infection of the Urinary Tract

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04287478

Enrollment

Registered

2020-02-27

Start date

2020-12-09

Completion date

2023-02-28

Last updated

2023-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infection Bacterial

Keywords

Antimicrobial Resistance, Bacteriophage, Urinary Tract Infections, Phage

Brief summary

This is a phase I/II trial designed to evaluate bacteriophage therapy in patients with urinary tract infections.

Detailed description

This study will evaluate the safety and efficacy of bacteriophage therapy in patients with urinary tract infection (UTI). Patients to be enrolled will have urinary tract infections due to E. coli and K. pneumoniae. This will include asymptomatic patients with neurogenic bladder and symptomatic patients with complicated urinary tract infections who are at risk of UTI recurrence. Patients will be followed for bacterial clearance or recurrence of urinary tract infection.

Interventions

BIOLOGICALBacteriophage Therapy

Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Masking description

Patient will be randomized to receive either active phage or placebo treatment.

Intervention model description

Initially, patients with neurogenic bladder and urinary tract infections will be enrolled and followed for bacterial eradication. Results from this cohort will be used to confirm or modify the phage dosing regimen before proceeding to the patients with symptomatic infection at risk of recurrence. The trial will use pre-specified criteria to determine what phage regimens should be evaluated.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

General Inclusion Criteria: * Males or females ≥18 years of age. * Female patients of childbearing potential. * Male patients must agree not to donate sperm up for one month. * English-speaking. General

Exclusion criteria

* Stage 4 or greater chronic kidney disease (CKD). * Abnormal liver function tests \>3×upper limit of normal (ULN). * Other conditions which could confound study results. * Body mass index of \> 40 or weight less than 50 kg. * Known allergy to phage products. * Pregnant and/or breastfeeding. * Immunocompromised. * Need for antiviral medication. * History of severe autonomic dysreflexia.

Design outcomes

Primary

Measure	Time frame	Description
Identify ideal bacteriophage treatment regimens based on improvements in disease control rates	baseline	Microbiological eradication of target pathogen identified at baseline

Secondary

Measure	Time frame	Description
Assess the safety of bacteriophage therapy	At least 56 days	Safety will be measured by the number and percent of treatment related adverse events.
Assess the tolerability of bacteriophage therapy	At least 56 days	Tolerability will be measured by the percentage of patients who discontinue treatment due to adverse events

Other

Measure	Time frame	Description
Recurrence of urinary tract infection	1 year	Recurrence of urinary tract infection for 1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026