Phage Therapy for the Treatment of Urinary Tract Infection
Primary Purpose
Recurrent Urinary Tract Infection
Status
Active
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Phage Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Urinary Tract Infection focused on measuring Phage Therapy, Recurrent urinary tract infection
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
Sites / Locations
- St. Joseph's Health Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open Label Arm
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05537519
First Posted
September 9, 2022
Last Updated
June 19, 2023
Sponsor
Unity Health Toronto
Collaborators
Applied Health Research Centre
1. Study Identification
Unique Protocol Identification Number
NCT05537519
Brief Title
Phage Therapy for the Treatment of Urinary Tract Infection
Official Title
Phage Therapy for the Treatment of Urinary Tract Infection
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
September 15, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Applied Health Research Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Urinary Tract Infection
Keywords
Phage Therapy, Recurrent urinary tract infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Label Arm
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Phage Therapy
Intervention Description
3-phage cocktail comprised of HP3, HP3.1 and ES19
Primary Outcome Measure Information:
Title
Safety and Tolerability
Description
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.
Time Frame
90 Days
Secondary Outcome Measure Information:
Title
Clinical and microbial response
Description
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.
Time Frame
90 Days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory German, MD PhD FRCPC
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Health Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6R 1B5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phage Therapy for the Treatment of Urinary Tract Infection
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