nctId: NCT06262282 id: NTM-OB-17 (PART C) briefTitle: Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria acronym: POSTSTAMP overallStatus: ENROLLING_BY_INVITATION date: 2024-02-05 date: 2026-12 date: 2028-12 date: 2024-02-16 date: 2024-02-16 name: National Jewish Health class: OTHER name: Cystic Fibrosis Foundation briefSummary: 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. conditions: Cystic Fibrosis conditions: Nontuberculous Mycobacterial Lung Disease conditions: Nontuberculous Mycobacterium Infection conditions: Mycobacterium Infections conditions: Mycobacterium; Pulmonary studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: mycobacteriophage measure: Adherence to therapy measure: Phage susceptibility measure: Culture conversion measure: Tolerance of treatment measure: Clinical Response (pulmonary function testing) measure: Microbiologic response to phage measure: Clinical response (BMI) measure: Clinical response (CFQR) measure: Clinical Response (antibiotic courses for non- NTM exacerbations) sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama city: Birmingham state: Alabama zip: 35233 country: United States lat: 33.52066 lon: -86.80249 facility: Children's Hospital of Los Angeles city: Los Angeles state: California zip: 90027 country: United States lat: 34.05223 lon: -118.24368 facility: University of California city: San Diego state: California zip: 92103 country: United States lat: 32.71533 lon: -117.15726 facility: Childrens Hospital Colorado city: Denver state: Colorado zip: 80045 country: United States lat: 39.73915 lon: -104.9847 facility: National Jewish Health city: Denver state: Colorado zip: 80206 country: United States lat: 39.73915 lon: -104.9847 facility: University of Florida city: Gainesville state: Florida zip: 32610 country: United States lat: 29.65163 lon: -82.32483 facility: Northwestern University city: Chicago state: Illinois zip: 60611 country: United States lat: 41.85003 lon: -87.65005 facility: John Hopkins University city: Baltimore state: Maryland zip: 21218 country: United States lat: 39.29038 lon: -76.61219 facility: Boston Childrens Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 facility: Dartmouth Hitchcock Medical Center city: Lebanon state: New Hampshire zip: 03756 country: United States lat: 43.64229 lon: -72.25176 facility: Columbia University city: New York state: New York zip: 10032 country: United States lat: 40.71427 lon: -74.00597 facility: University of North Carolina at Chapel Hill city: Chapel Hill state: North Carolina zip: 27599 country: United States lat: 35.9132 lon: -79.05584 facility: Nationwide Children's Hospital city: Columbus state: Ohio zip: 43215 country: United States lat: 39.96118 lon: -82.99879 facility: University of Pittsburgh Medical Center city: Pittsburgh state: Pennsylvania zip: 15213 country: United States lat: 40.44062 lon: -79.99589 facility: Southwestern Medical Center at Dallas city: Dallas state: Texas zip: 75390 country: United States lat: 32.78306 lon: -96.80667 facility: University of Vermont city: Burlington state: Vermont zip: 05401 country: United States lat: 44.47588 lon: -73.21207 facility: University of Washington city: Seattle state: Washington zip: 98195 country: United States lat: 47.60621 lon: -122.33207 hasResults: False