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Phage Therapy for the Treatment of Urinary Tract Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05537519
Recruitment Status : Active, not recruiting
First Posted : September 13, 2022
Last Update Posted : June 22, 2023
Sponsor:
Collaborator:
Applied Health Research Centre
Information provided by (Responsible Party):
Unity Health Toronto

Study Description
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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.

Condition or disease Intervention/treatment Phase
Recurrent Urinary Tract Infection Biological: Phage Therapy Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phage Therapy for the Treatment of Urinary Tract Infection
Actual Study Start Date : May 1, 2023
Estimated Primary Completion Date : September 15, 2025
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Open Label Arm Biological: Phage Therapy
3-phage cocktail comprised of HP3, HP3.1 and ES19


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: 90 Days ]

    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 :
  1. Clinical and microbial response [ Time Frame: 90 Days ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05537519


Locations
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Canada, Ontario
St. Joseph's Health Centre
Toronto, Ontario, Canada, M6R 1B5
Sponsors and Collaborators
Unity Health Toronto
Applied Health Research Centre
Investigators
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Principal Investigator: Gregory German, MD PhD FRCPC Unity Health Toronto
More Information
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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT05537519    
Other Study ID Numbers: Phage Therapy 001
First Posted: September 13, 2022    Key Record Dates
Last Update Posted: June 22, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Unity Health Toronto:
Phage Therapy
Recurrent urinary tract infection
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Urinary Tract Infections
Disease Attributes
Pathologic Processes
 Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases