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