Actively Recruiting
Biomarker Study of Response to Bacteriophage Treatment for Nontuberculous Mycobacterial Lung Disease and Other Infections A Single-Center Observational Investigation
Led by NYU Langone Health · Updated on 2025-10-30
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Biomarkers of Phage Treatment Response in NTM and Other Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Provided appropriate written consent
- Willing and able to participate in study procedures
- Diagnosed with bacterial or mycobacterial infection meeting criteria for treatment
- Considered by clinician for phage therapy as part of standard care
You will not qualify if you...
- Under 18 years of age
- Pregnant individuals due to unknown risks of phage treatment
- Breastfeeding individuals due to unknown risk to the infant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 2 years
Participants are observed with blood and airway samples collected during follow-up visits to study biomarkers related to infection and treatment response.
Follow-up visits as determined by clinical care
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
D
Doreen Addrizzo-Harris, MD, FCCP
L
Lira Gutierrez
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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