- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05314426
Mayo Clinic Phage Program Biobank
June 10, 2025 updated by: Gina A. Suh, Mayo Clinic
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 Overview
Status
Enrolling by invitation
Conditions
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Mayo Clinic patients receiving bacteriophage therapy.
Description
Inclusion Criteria:
- ≥ 18 years of age.
- Able to provide informed consent.
- Individual must have a future treatment plan to receive or has historically received phage therapy.
Exclusion Criteria:
- Individuals , 18 years of age.
- Unwilling/unable to provide informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
5 years
|
|
Collection of biospecimens
Time Frame: 5 years
|
Total number of biospecimens collected which may include blood samples and synovial fluid
|
5 years
|
|
Medical record review
Time Frame: 5 years
|
Review the medical record of enrolled participants to ascertain any new health outcomes.
|
5 years
|
|
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.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gina Suh, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 19, 2022
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
March 30, 2022
First Submitted That Met QC Criteria
March 30, 2022
First Posted (Actual)
April 6, 2022
Study Record Updates
Last Update Posted (Actual)
June 12, 2025
Last Update Submitted That Met QC Criteria
June 10, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 21-013112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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