Phage Therapy for the Treatment of Urinary Tract Infection

NCT ID: NCT05537519

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-06-30

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.

Conditions

Recurrent Urinary Tract Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open Label Arm

Group Type: EXPERIMENTAL

Phage Therapy

Intervention Type: BIOLOGICAL

3-phage cocktail comprised of HP3, HP3.1 and ES19

Interventions

Phage Therapy

3-phage cocktail comprised of HP3, HP3.1 and ES19

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Applied Health Research Centre

OTHER

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory German, MD PhD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Joseph's Health Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

Phage Therapy 001

Identifier Type: -

Identifier Source: org_study_id