NCT05314426

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Apr 2022Apr 2027

First Submitted

Initial submission to the registry

March 30, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

April 19, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

5 years

First QC Date

March 30, 2022

Last Update Submit

June 10, 2025

Conditions

Bacteriophage Therapy

Outcome Measures

Primary Outcomes (4)

  • Enrollment of study participants

    To recruit and enroll participants up to 100 participants who have received or will receive phage therapy treatment

    5 years

  • Collection of biospecimens

    Total number of biospecimens collected which may include blood samples and synovial fluid

    5 years

  • Medical record review

    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

    Total number of collaborations with clinical investigators and researchers at both Mayo Clinic and across the globe.

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mayo Clinic patients receiving bacteriophage therapy.

You may qualify if:

  • ≥ 18 years of age.
  • Able to provide informed consent.
  • Individual must have a future treatment plan to receive or has historically received phage therapy.

You may not qualify if:

  • Individuals , 18 years of age.
  • Unwilling/unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and synovial fluid will be stored in the biorepository for future research.

Study Officials

  • Gina Suh, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 6, 2022

Study Start

April 19, 2022

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)