Phage Therapy for the Treatment of Urinary Tract Infection

Recurrent Urinary Tract Infection Clinical Trial

Official title:

Phage Therapy for the Treatment of Urinary Tract Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05537519
• Other study ID #: Phage Therapy 001
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: May 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Unity Health Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: June 30, 2024
• Est. primary completion date: July 28, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Recurrent Urinary Tract Infection
• Urinary Tract Infections

Intervention

Biological:
• Phage Therapy
3-phage cocktail comprised of HP3, HP3.1 and ES19

Locations

Country	Name	City	State
Canada	St. Joseph's Health Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Unity Health Toronto	Applied Health Research Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	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.	90 Days
Secondary	Clinical and microbial response	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.	90 Days