Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria

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.

NCT Number	NCT06262282
Lead Sponsor	National Jewish Health Collaborators: Cystic Fibrosis Foundation
Conditions	Cystic Fibrosis, Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterium Infection, Mycobacterium Infections, Mycobacterium; Pulmonary
Enrollment	10 participants
Start Date	2024-02-05
Primary Completion	2026-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-21