Bacteriophage TherapyNCT05314426
Mayo Clinic Phage Program Biobank
An observational study of Bacteriophage Therapy, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to help scientists and clinicians discover answers to research questions related to antibiotic-resistant bacterial infections, and the role that phage therapy plays as a possible treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteriophage Therapy
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2022to Apr 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Mayo Clinic patients receiving bacteriophage therapy.
Who may be able to join
- ≥ 18 years of age.
- Able to provide informed consent.
- Individual must have a future treatment plan to receive or has historically received phage therapy.
Who cannot join
- Individuals , 18 years of age.
- Unwilling/unable to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to help scientists and clinicians discover answers to research questions related to antibiotic-resistant bacterial infections, and the role that phage therapy plays as a possible treatment.
- Conditions
- Bacteriophage Therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment of study participants
To recruit and enroll participants up to 100 participants who have received or will receive phage therapy treatment
Measured: 5 years
Collection of biospecimens
Total number of biospecimens collected which may include blood samples and synovial fluid
Measured: 5 years
Medical record review
Review the medical record of enrolled participants to ascertain any new health outcomes.
Measured: 5 years
Increase treatment options and level of care for patients with bacterial infections
Total number of collaborations with clinical investigators and researchers at both Mayo Clinic and across the globe.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start19 Apr 2022
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacteriophage TherapyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gina A. Suh, Mayo Clinic
- Investigators
- Gina Suh, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314426
- Sponsor's protocol ID
- 21-013112
- Status last verified
- Jun 2026
- First submitted
- 30 Mar 2022
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mayo Clinic Phage Program Biobank
- ClinicalTrials.gov ID
- NCT05314426
- Acronym / sponsor ID
- 21-013112
- Conditions
- Bacteriophage Therapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 6 Apr 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.
The purpose of this study is to help scientists and clinicians discover answers to research questions related to antibiotic-resistant bacterial infections, and the role that phage therapy plays as a possible treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mayo Clinic patients receiving bacteriophage therapy.
Key inclusion criteria (3 listed)
- ≥ 18 years of age.
- Able to provide informed consent.
- Individual must have a future treatment plan to receive or has historically received phage therapy.
Key exclusion criteria (2 listed)
- Individuals , 18 years of age.
- Unwilling/unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Enrollment of study participants
Time frame: 5 years
To recruit and enroll participants up to 100 participants who have received or will receive phage therapy treatment
Collection of biospecimens
Time frame: 5 years
Total number of biospecimens collected which may include blood samples and synovial fluid
Medical record review
Time frame: 5 years
Review the medical record of enrolled participants to ascertain any new health outcomes.
Increase treatment options and level of care for patients with bacterial infections
Time frame: 5 years
Total number of collaborations with clinical investigators and researchers at both Mayo Clinic and across the globe.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Bacteriophage Therapy
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RecruitingObservational study
Establishing Personalized Phage Therapy and Its Comparative Cost in Difficult-to-treat Infections (EPHICACI)
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A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)
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Biomarkers of Phage Treatment Response in NTM and Other Infections
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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.
Gina Suh, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteriophage Therapy, run by Mayo Clinic at 1 site 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?
The sponsor lists 3 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 24 Jun 2026. 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 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Enrollment of study participants (time frame: 5 years). The study lists 4 primary outcomes in all. 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 24 Jun 2026.