Phage Therapy for the Treatment of Urinary Tract Infection

Phase 1

Active, not recruiting

• Conditions: Recurrent Urinary Tract Infection
• Interventions: Biological: Phage Therapy

• Registration Number: NCT05537519
• Lead Sponsor: Unity Health Toronto

Brief Summary

This is a single-patient, phase I/II clinical trial that aims to evaluate the potential of bacteriophage therapy to treat and prevent the recurrence of a drug-resistant urinary tract infection with serious long-term effects. This study will follow a minimally invasive phage therapy approach consisting of oral, topical (opening of the urethra) and bladder installations of a 3-phage cocktail comprised of HP3, HP3.1 and ES19.

Detailed Description

This is a single-patient, phase I/II clinical trial that aims to evaluate the potential of bacteriophage therapy to treat and prevent the recurrence of a drug-resistant urinary tract infection. This study will follow a minimally invasive phage therapy approach consisting of oral, topical and bladder installations of a 3-phage cocktail comprised of HP3, HP3.1 and ES19.

Oral and bladder installation of bacteriophages will be administered on day 1 - and potentially day 7 depending on day 5 urine and stool lab results - and a topical preparation will be applied externally to the urethra for 30-minutes on days 1 to 3. However, if the participant is still experiencing mild symptoms on day 5, systemic antibiotics will be administered in combination with phage therapy.

The primary objective is to determine the safety and tolerability of minimally invasive bacteriophage therapy for treating recurrent urinary tract infections with severe long-term effects.

The secondary objective is to evaluate the 90-day clinical and microbial response to the minimally invasive administration of bacteriophages for recurrent urinary tract infections with severe long-term outcomes.

The total duration of participant involvement is 2 years, while the study is estimated to be completed in 3 years.

Study Timeline

• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-13
• Study Start: 2023-05-01
• Primary Completion: 2023-07-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

• Diagnosis of recurrent chronic urinary tract infections with severe long term effects
• Can speak and understand English
• Willing to follow the protocol

Exclusion Criteria

• Stage 5 chronic kidney disease
• Abnormal liver function tests
• A urinary stent or chronic indwelling catheterization
• A known allergy to phage products
• Fever
• Pregnancy
• Involved in another clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label Arm	Phage Therapy	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	90 Days	The primary objective is to determine the safety and tolerability of minimally invasive bacteriophage therapy for treating recurrent urinary tract infections with severe long-term effects.; These will be assessed through the use of a daily symptom questionnaire, adverse events (AEs), clinical and research laboratory results.

Secondary Outcome Measures

Name	Time	Method
Clinical and microbial response	90 Days	The secondary objective is to evaluate the 90-day clinical outcomes through a daily paper questionnaire and microbial response assessed through a series of blood, urine, stool, and vaginal sample, to the minimally invasive administration of bacteriophages for recurrent urinary tract infections with severe long-term outcomes.

Trial Locations

Locations (1)

St. Joseph's Health Centre; 🇨🇦 Toronto, Ontario, Canada