Phage Therapy for the Treatment of Urinary Tract Infection
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2022
CompletedFirst Posted
Study publicly available on registry
September 13, 2022
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedMarch 26, 2024
March 1, 2024
3 months
September 9, 2022
March 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Clinical and microbial response
90 Days
Study Arms (1)
Open Label Arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of recurrent chronic urinary tract infections with severe long term effects
- Can speak and understand English
- Willing to follow the protocol
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unity Health Torontolead
- Applied Health Research Centrecollaborator
Study Sites (1)
St. Joseph's Health Centre
Toronto, Ontario, M6R 1B5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory German, MD PhD FRCPC
Unity Health Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2022
First Posted
September 13, 2022
Study Start
May 1, 2023
Primary Completion
July 28, 2023
Study Completion
June 30, 2024
Last Updated
March 26, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share