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Biomarkers of Phage Treatment Response in NTM and Other Infections

NCT07076238 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-10-30

No results posted yet for this study

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

BIOLOGICAL

Bacteriophage Treatment

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

Sponsors & Collaborators

Principal Investigators

  • Doreen Addrizzo-Harris, MD, FCCP · NYU Langone Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-25
Primary Completion
2030-06-25
Completion
2032-06-25

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07076238 on ClinicalTrials.gov