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Trial record 1 of 718 for:    Urinary Tract Infections
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05537519
Recruitment Status : Not yet recruiting
First Posted : September 13, 2022
Last Update Posted : September 13, 2022
Sponsor:
Collaborator:
Applied Health Research Centre
Information provided by (Responsible Party):
Gregory German, Unity Health Toronto

Brief Summary:
This is a single-patient, phase 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 Early Phase 1

Detailed Description:

This is a single-patient, phase 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 15, 2022
Estimated Primary Completion Date : September 15, 2025
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine


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




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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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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

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


Contacts
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Contact: Gregory German, MD PhD FRCPC 416-530-6000 ext 4005 Gregory.German@unityhealth.to
Contact: Carlos Fernando, MD MSc MBA 416-864-6060 ext 46969 Carlos.Fernando@unityhealth.to

Locations
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Canada, Ontario
St. Joseph's Health Centre
Toronto, Ontario, Canada, M6R 1B5
Contact: Gregory German, MD PhD FRCPC    416-530-6000 ext 4005    Gregory.German@unityhealth.to   
Contact: Carlos Fernando, MD MSc MBA    416-864-6060 ext 46969    Carlos.Fernando@unityhealth.to   
Sponsors and Collaborators
Gregory German
Applied Health Research Centre
Investigators
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Principal Investigator: Gregory German, MD PhD FRCPC Unity Health Toronto
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Responsible Party: Gregory German, Medical Microbiologist,Staff Physician Chronic Infection Clinic. Assistant Professor, Department of Department of Laboratory Medicine & Pathobiology, University of Toronto, 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: September 13, 2022
Last Verified: September 2022
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 Gregory German, 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