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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 : March 26, 2024
Sponsor:
Collaborator:
Applied Health Research Centre
Information provided by (Responsible Party):
Unity Health Toronto

Tracking Information
First Submitted Date  ICMJE September 9, 2022
First Posted Date  ICMJE September 13, 2022
Last Update Posted Date March 26, 2024
Actual Study Start Date  ICMJE May 1, 2023
Actual Primary Completion Date July 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2023)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2022)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2023)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2022)
Clinical and microbial response [ Time Frame: 90 Days ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phage Therapy for the Treatment of Urinary Tract Infection
Official Title  ICMJE Phage Therapy for the Treatment of Urinary Tract Infection
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Urinary Tract Infection
Intervention  ICMJE Biological: Phage Therapy
3-phage cocktail comprised of HP3, HP3.1 and ES19
Study Arms  ICMJE Experimental: Open Label Arm
Intervention: Biological: Phage Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 9, 2022)
1
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2024
Actual Primary Completion Date July 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05537519
Other Study ID Numbers  ICMJE Phage Therapy 001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Unity Health Toronto
Original Responsible Party Gregory German, Unity Health Toronto, Medical Microbiologist,Staff Physician Chronic Infection Clinic. Assistant Professor, Department of Department of Laboratory Medicine & Pathobiology, University of Toronto
Current Study Sponsor  ICMJE Unity Health Toronto
Original Study Sponsor  ICMJE Gregory German
Collaborators  ICMJE Applied Health Research Centre
Investigators  ICMJE
Principal Investigator: Gregory German, MD PhD FRCPC Unity Health Toronto
PRS Account Unity Health Toronto
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP