Phage Therapy for the Treatment of Urinary Tract Infection

Unity Health Toronto

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Recurrent Urinary Tract Infection

Treatments: Biological: Phage Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05537519

Phage Therapy 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Open Label Arm

Experimental group

Treatment:

Biological: Phage Therapy