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ENROLLING BY INVITATION
NCT06262282

Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria

Sponsor: National Jewish Health

View on ClinicalTrials.gov

Summary

About 10 people with cystic fibrosis (CF) and persistent Nontuberculosis mycobacteria (NTM) infection despite treatment will be screened to find out if their NTM infection has at least one mycobacteriophage that is effective in killing the mycobacteria. Individuals who are found to have at least one phage will be offered assistance in pursuing FDA approval for treatment via expanded-access Individual New Drug (IND) for compassionate-use. They will receive phage treatment for 1 year along with their guideline-based antibiotics for NTM. Individuals who are not identified as having a phage match will be followed as they continue to receive guideline based antibiotic therapy for 1 year. All subjects, including those who do not have a phage match will continue to be observed for the duration of the study, or about 1 year.

Official title: A Prospective Standardized Assessment of People With Cystic Fibrosis and Non-tuberculosis Mycobacteria Pulmonary Disease Undergoing Treatment With Mycobacteriophage (POSTSTAMP)

Key Details

Gender

All

Age Range

6 Years - Any

Study Type

OBSERVATIONAL

Enrollment

10

Start Date

2024-02-05

Completion Date

2028-12-31

Last Updated

2025-05-21

Healthy Volunteers

No

Interventions

BIOLOGICAL

mycobacteriophage

mycobacteriophage phage that has been found effective in killing participants NTM infection

Locations (18)

University of Alabama

Birmingham, Alabama, United States

Children's Hospital of Los Angeles

Los Angeles, California, United States

University of California

San Diego, California, United States

Childrens Hospital Colorado

Denver, Colorado, United States

National Jewish Health

Denver, Colorado, United States

University of Florida

Gainesville, Florida, United States

Northwestern University

Chicago, Illinois, United States

John Hopkins University

Baltimore, Maryland, United States

Boston Childrens Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Columbia University

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Southwestern Medical Center at Dallas

Dallas, Texas, United States

University of Vermont

Burlington, Vermont, United States

University of Washington

Seattle, Washington, United States