RecruitingNCT07076238

Biomarkers of Phage Treatment Response in NTM and Other Infections

A Single-Center Observational Biomarker Investigation of Response to Bacteriophage Treatment for Bacterial Infection


Sponsor

NYU Langone Health

Enrollment

100 participants

Start Date

Jun 25, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This study aims to identify biomarkers associated with response to phage therapy for refractory bacterial infections. This includes mycobacteriophage treatment for patients with nontuberculous mycobacterial infections. Blood and airway samples will be obtained from follow up visits of patients with refractory bacterial infections that are considered for phage therapy. Samples will be compared between those that receive phage therapy and those that did not. Biomarkers will include changes in the airway microbiome, transcriptome, inflammatory cytokines, and development of neutralizing antibody against phages. The primary endpoint is to identify biomarkers associated with clinical and/or radiographic improvement and/or culture improvement which includes clearing of cultures or decrease in qualitative or resolution of signs and symptoms of infection after at least 6-8 weeks of bacteriophage therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Bacteriophage Treatment for people with nontuberculous mycobacterial lung disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBacteriophage Treatment

Participants who have a positive match for their NTM isolate will start on mycobacteriophage treatment per prescribed treatment regimen.


Locations(1)

NYU Langone Health

New York, New York, United States

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NCT07076238


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