Actively Recruiting

Age: 18Years +
All Genders
NCT07076238

Biomarkers of Phage Treatment Response in NTM and Other Infections

Led by NYU Langone Health · Updated on 2025-10-30

100

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Biomarkers of Phage Treatment Response in NTM and Other Infections

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years of age or older
  • Provide written consent
  • Willing and able to participate in study procedures
  • Diagnosis of bacterial or mycobacterial infection meeting clinical, radiographic, and microbiologic criteria for treatment
  • Being considered by a clinician for phage therapy as part of standard care
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

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Research Team

D

Doreen Addrizzo-Harris, MD, FCCP

CONTACT

L

Lira Gutierrez

CONTACT

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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