Phage Therapy for the Treatment of Urinary Tract Infection
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|ClinicalTrials.gov Identifier: NCT05537519|
Recruitment Status : Not yet recruiting
First Posted : September 13, 2022
Last Update Posted : September 13, 2022
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Urinary Tract Infection||Biological: Phage Therapy||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Open Label Arm||
Biological: Phage Therapy
3-phage cocktail comprised of HP3, HP3.1 and ES19
- 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.
- 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.
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
|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|
|Principal Investigator:||Gregory German, MD PhD FRCPC||Unity Health Toronto|