Phage Therapy for the Treatment of Urinary Tract Infection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phage Therapy for the Treatment of Urinary Tract Infection

Conditions
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Recurrent Urinary Tract Infection

Intervention / Treatment
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* Biological: Phage Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label Arm<br> | Biological: Phage Therapy<br>* 3-phage cocktail comprised of HP3, HP3.1 and ES19<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability | 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. | 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and microbial response | 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. | 90 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phage Therapy, Recurrent urinary tract infection