Urinary Tract Infection BacterialPhase 1/2NCT04287478
Bacteriophage Therapy in Patients With Urinary Tract Infections
A Phase 1/2 study testing Bacteriophage Therapy in people with Urinary Tract Infection Bacterial, run by Adaptive Phage Therapeutics, Inc. at 8 sites in United States.
Trial summary
This is a phase I/II trial designed to evaluate bacteriophage therapy in patients with urinary tract infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection Bacterial
- What is being tested?
- Bacteriophage Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 8 sitesUnited States
- Study dates
- 9 Dec 2020to 28 Feb 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
General Inclusion Criteria:
- Males or females ≥18 years of age.
- Female patients of childbearing potential.
- Male patients must agree not to donate sperm up for one month.
- English-speaking.
General Exclusion Criteria:
- Stage 4 or greater chronic kidney disease (CKD).
- Abnormal liver function tests >3×upper limit of normal (ULN).
- Other conditions which could confound study results.
- Body mass index of > 40 or weight less than 50 kg.
- Known allergy to phage products.
- Pregnant and/or breastfeeding.
- Immunocompromised.
- Need for antiviral medication.
- History of severe autonomic dysreflexia.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Henry Ford Hospital
Detroit, Michigan, 48202
Universal Axon Clinical Research
Doral, Florida, 33166
DHR Health Institute for Research and Development
Edinburg, Texas, 78539
AdMed Research
Miami, Florida, 33176
AMPM Research Clinic
Miami Gardens, Florida, 33169
Innovation Medical Research Center, Inc
Palmetto Bay, Florida, 33157
James J. Peters VA Medical Center
The Bronx, New York, 10468
About this study
Official title: A Phase I/II Study of Bacteriophage Therapy to Evaluate Safety, Tolerability, and Efficacy of Targeted "Personalized" Bacteriophage Treatments in Patients With Bacterial Infection of the Urinary Tract
This is a phase I/II trial designed to evaluate bacteriophage therapy in patients with urinary tract infections.
Read the detailed description
This study will evaluate the safety and efficacy of bacteriophage therapy in patients with urinary tract infection (UTI). Patients to be enrolled will have urinary tract infections due to E. coli and K. pneumoniae. This will include asymptomatic patients with neurogenic bladder and symptomatic patients with complicated urinary tract infections who are at risk of UTI recurrence. Patients will be followed for bacterial clearance or recurrence of urinary tract infection.
- Conditions
- Urinary Tract Infection Bacterial
- Being tested
- Bacteriophage Therapy
- Keywords
- Antimicrobial Resistance, Bacteriophage, Urinary Tract Infections, Phage
- 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.
Bacteriophage TherapyBiological
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
| Study group | Role | What they receive |
|---|---|---|
| Intravenous (IV) | Experimental | Phage administered via the intravenous route. Receives: Biological: Bacteriophage Therapy |
| Intravesical (IVS) | Experimental | Phage administered via the intravesical route. Receives: Biological: Bacteriophage Therapy |
| Subcohort A | Experimental | Selected phage for E. coli administered via selected route based on previous Arms. Receives: Biological: Bacteriophage Therapy |
| Subcohort B | Experimental | Selected phage for Klebsiella pneumoniae administered via selected route based on previous Arms. Receives: Biological: Bacteriophage Therapy |
| Subcohort C | Experimental | Selected phage for E. coli administered via selected route based on previous Arms. Receives: Biological: Bacteriophage Therapy |
| Subcohort D | Experimental | Selected phage for Klebsiella pneumoniae administered via selected route based on previous arms. Receives: Biological: Bacteriophage Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify ideal bacteriophage treatment regimens based on improvements in disease control rates
Microbiological eradication of target pathogen identified at baseline
Measured: baseline
Secondary outcomes (2)
Assess the safety of bacteriophage therapy
Safety will be measured by the number and percent of treatment related adverse events.
Measured: At least 56 days
Assess the tolerability of bacteriophage therapy
Tolerability will be measured by the percentage of patients who discontinue treatment due to adverse events
Measured: At least 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start9 Dec 2020
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Why it stopped: Study terminated due to a change in development strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infection BacterialStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Sequential
- Model description
- Initially, patients with neurogenic bladder and urinary tract infections will be enrolled and followed for bacterial eradication. Results from this cohort will be used to confirm or modify the phage dosing regimen before proceeding to the patients with symptomatic infection at risk of recurrence. The trial will use pre-specified criteria to determine what phage regimens should be evaluated.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaptive Phage Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Robert J Hopkins, MD, Principal investigator, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287478
- Sponsor's protocol ID
- APT.UTI.001
- Status last verified
- Mar 2023
- First submitted
- 3 Feb 2020
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Bacteriophage Therapy to Evaluate Safety, Tolerability, and Efficacy of Targeted "Personalized" Bacteriophage Treatments in Patients With Bacterial Infection of the Urinary Tract
- ClinicalTrials.gov ID
- NCT04287478
- Acronym / sponsor ID
- APT.UTI.001
- Conditions
- Urinary Tract Infection Bacterial
- Keywords
- Antimicrobial Resistance, Bacteriophage, Urinary Tract Infections, Phage
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to a change in development strategy.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Adaptive Phage Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 27 Feb 2020 (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 phase I/II trial designed to evaluate bacteriophage therapy in patients with urinary tract infections.
Detailed description
This study will evaluate the safety and efficacy of bacteriophage therapy in patients with urinary tract infection (UTI). Patients to be enrolled will have urinary tract infections due to E. coli and K. pneumoniae. This will include asymptomatic patients with neurogenic bladder and symptomatic patients with complicated urinary tract infections who are at risk of UTI recurrence. Patients will be followed for bacterial clearance or recurrence of urinary tract infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Initially, patients with neurogenic bladder and urinary tract infections will be enrolled and followed for bacterial eradication. Results from this cohort will be used to confirm or modify the phage dosing regimen before proceeding to the patients with symptomatic infection at risk of recurrence. The trial will use pre-specified criteria to determine what phage regimens should be evaluated.
| Arm | Type | Receives |
|---|---|---|
| Intravenous (IV) | Experimental | Biological: Bacteriophage TherapyPhage administered via the intravenous route. |
| Intravesical (IVS) | Experimental | Biological: Bacteriophage TherapyPhage administered via the intravesical route. |
| Subcohort A | Experimental | Biological: Bacteriophage TherapySelected phage for E. coli administered via selected route based on previous Arms. |
| Subcohort B | Experimental | Biological: Bacteriophage TherapySelected phage for Klebsiella pneumoniae administered via selected route based on previous Arms. |
| Subcohort C | Experimental | Biological: Bacteriophage TherapySelected phage for E. coli administered via selected route based on previous Arms. |
| Subcohort D | Experimental | Biological: Bacteriophage TherapySelected phage for Klebsiella pneumoniae administered via selected route based on previous arms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Bacteriophage TherapyBacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing | Biological | Intravenous (IV), Intravesical (IVS), Subcohort A, Subcohort B, Subcohort C, Subcohort D |
Primary outcome
Identify ideal bacteriophage treatment regimens based on improvements in disease control rates
Time frame: baseline
Microbiological eradication of target pathogen identified at baseline
2 secondary outcomes
Assess the safety of bacteriophage therapy
Time frame: At least 56 days
Assess the tolerability of bacteriophage therapy
Time frame: At least 56 days
Results and safety
The study was stopped early (reason given: Study terminated due to a change in development strategy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
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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.
Robert J Hopkins, MD principal investigator
Chief Medical Officer
8 sites 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 Bacteriophage Therapy in people with Urinary Tract Infection Bacterial, run by Adaptive Phage Therapeutics, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
The study was stopped early (reason given: Study terminated due to a change in development strategy.). 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?
Identify ideal bacteriophage treatment regimens based on improvements in disease control rates (time frame: baseline). 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 3 Mar 2023.