Recurrent Urinary Tract InfectionPhase 1/2NCT05537519
Phage Therapy for the Treatment of Urinary Tract Infection
A Phase 1/2 study testing Phage Therapy in people with Recurrent Urinary Tract Infection, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Urinary Tract Infection
- What is being tested?
- Phage Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2023to 30 Jun 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of recurrent chronic urinary tract infections with severe long term effects
- Can speak and understand English
- Willing to follow the protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Recurrent Urinary Tract Infection
- Being tested
- Phage Therapy
- Keywords
- Phage Therapy, Recurrent urinary tract infection
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phage TherapyBiological
3-phage cocktail comprised of HP3, HP3.1 and ES19
| Study group | Role | What they receive |
|---|---|---|
| Open Label Arm | Experimental | Not described Receives: Biological: Phage Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 Days
Secondary outcomes (1)
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.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 May 2023
- Primary completion28 Jul 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Applied Health Research Centre
- Responsible party
- Sponsor
- Investigators
- Gregory German, MD PhD FRCPC, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537519
- Sponsor's protocol ID
- Phage Therapy 001
- Status last verified
- Mar 2024
- First submitted
- 9 Sep 2022
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phage Therapy for the Treatment of Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT05537519
- Acronym / sponsor ID
- Phage Therapy 001
- Conditions
- Recurrent Urinary Tract Infection
- Keywords
- Phage Therapy, Recurrent urinary tract infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Applied Health Research Centre
- Study start
- 1 May 2023 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Arm | Experimental | Biological: Phage Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of recurrent chronic urinary tract infections with severe long term effects
- Can speak and understand English
- Willing to follow the protocol
Key exclusion criteria (7 listed)
- Stage 5 chronic kidney disease
- Abnormal liver function tests
- A urinary stent or chronic indwelling catheterization
- A known allergy to phage products
- Fever
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phage Therapy3-phage cocktail comprised of HP3, HP3.1 and ES19 | Biological | Open Label Arm |
Primary outcome
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.
1 secondary outcome
Clinical and microbial response
Time frame: 90 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Recurrent Urinary Tract Infection
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
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Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)
Recurrent Urinary Tract Infections
RecruitingPhase 3
Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women
Recurrent Urinary Tract Infections in Women
Active, not recruiting
Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.
Recurrent Urinary Tract Infection
RecruitingPhase 4
Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study
Urinary Tract Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory German, MD PhD FRCPC principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Phage Therapy in people with Recurrent Urinary Tract Infection, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.