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Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria
Sponsor: National Jewish Health
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
Conditions
Interventions
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