Clinical trial NCT05537519: Phage Therapy for the Treatment of Urinary Tract Infection
Official title: Phage Therapy for the Treatment of Urinary Tract Infection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Recurrent Urinary Tract Infection
Keywords: Phage Therapy
Recurrent urinary tract infection
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Applied Health Research Centre
First posted: 2022-09-13
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 90 Days
Secondary outcomes:
measure: Clinical and microbial response
timeFrame: 90 Days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Gregory German, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: