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RECRUITING
NCT07076238

Biomarkers of Phage Treatment Response in NTM and Other Infections

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-06-25

Completion Date

2032-06-25

Last Updated

2025-10-30

Healthy Volunteers

No

Interventions

BIOLOGICAL

Bacteriophage 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