Phage Therapy for the Treatment of Urinary Tract Infection

Sponsor

Gregory German (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05537519

Collaborator

Applied Health Research Centre (Other)

Enrollment

Location

Arm

38.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Oct 15, 2022

Anticipated Primary Completion Date :

Sep 15, 2025

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Open Label Arm

Biological: Phage Therapy

3-phage cocktail comprised of HP3, HP3.1 and ES19

Outcome Measures

Primary Outcome Measures

Safety and Tolerability [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

Clinical and microbial response [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Health Centre	Toronto	Ontario	Canada	M6R 1B5

Sponsors and Collaborators

Gregory German
Applied Health Research Centre

Investigators

Principal Investigator: Gregory German, MD PhD FRCPC, Unity Health Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Sep 13, 2022

Last Update Posted:

Sep 13, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gregory German, Medical Microbiologist,Staff Physician Chronic Infection Clinic. Assistant Professor, Department of Department of Laboratory Medicine & Pathobiology, University of Toronto, Unity Health Toronto

Phage Therapy

Recurrent urinary tract infection

Additional relevant MeSH terms:

Infections

Communicable Diseases

Urinary Tract Infections

Study Results

No Results Posted as of Sep 13, 2022