Study of Biomarkers in Adults Receiving Bacteriophage Treatment for Nontuberculous Mycobacterial Lung Disease

What this Trial Is About

Researchers are investigating biomarkers linked to the response to phage therapy in patients with refractory bacterial infections, including those with nontuberculous mycobacterial NTM lung disease. The study aims to find biological markers that indicate clinical, radiographic, or culture improvements after at least 6 to 8 weeks of bacteriophage treatment. This observational study is conducted by NYU Langone Health and focuses on understanding how phage therapy affects infection outcomes. Participants who have a positive match for their NTM bacterial isolate will receive mycobacteriophage treatment following a prescribed regimen. Blood and airway samples will be collected during follow-up visits from both those receiving phage therapy and those who do not, allowing comparison of biomarker changes such as airway microbiome shifts, gene expression, inflammatory markers, and neutralizing antibodies against phages. Throughout the study, participants will provide blood and leftover airway samples during their scheduled follow-ups. Researchers will monitor various biomarkers to correlate them with clinical signs, radiographic findings, and culture results indicating infection improvement. The primary outcome focuses on identifying biomarkers related to positive treatment response over a period of up to two years. Safety and antibody development will also be assessed to better understand phage therapy effects.

Biomarkers of Phage Treatment Response in NTM and Other Infections