NCT07076238

Biomarkers of Phage Treatment Response in NTM and Other Infections

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nontuberculous Mycobacterial Lung Disease

Interventions

Type	Name	Description
BIOLOGICAL	Bacteriophage Treatment	Participants who have a positive match for their NTM isolate will start on mycobacteriophage treatment per prescribed treatment regimen.

Timeline

• Start date: 2025-06-25
• Primary completion: 2030-06-25
• Completion: 2032-06-25
• First posted: 2025-07-22
• Last updated: 2025-10-30

Locations

1 site across 1 country: United States