Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria

Prior treatment

• Prior or ongoing phage therapy for the species of NTM under consideration.

Other illness

• History of solid organ or hematological transplantation
• Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Other

• Pregnant or breastfeeding

• Written informed consent (and assent when applicable) obtained from participant or participant's legal representative
• Enrolled in the CFF Patient Registry (CFF PR)
• Be willing to adhere to study procedures in the context of clinical care, and other protocol requirements
• Male or female participant ≥ 6 years of age at enrollment who are able to reliably expectorate sputum and/or willing to undergo sputum induction (if necessary)
• Diagnosis of CF consistent with the 2017 CFF Guidelines
• NTM pulmonary disease on treatment with guideline-based antibiotics for \>12 months without consistent conversion of airway cultures to negative.
• Physician intention to treat NTM with phage therapy (if susceptible)
• Be willing and able to continue guideline-based antibiotics for NTM concurrent with phage.
• Documentation of a sufficient number of NTM cultures with a sufficient proportion of positive cultures in the interval 12 months prior to initiation of phage to allow for a within-subject power ≥0.80 to detect a difference in the percent positive NTM cultures in the interval 6-18 months following initiation of phage.