Biomarkers of Phage Treatment Response in NTM and Other Infections

NYU Langone Health100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Nontuberculous Mycobacterial Lung Disease

Interventions

Bacteriophage TreatmentBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adults 18 years of age or older 2. Provision of appropriate written consent 3. Willingness and ability to participate in study procedures 4. Diagnosis of bacterial/mycobacterial infection that meets criteria for treatment (clinical, radiographic, and microbiologic data) 5. Patients are being considered by clinician for phage therapy as a part of their standard of care Exclusion Criteria: 1. Patients under 18 years of age 2. Pregnant individuals as this population is not considered for phage treatment due to unknown risks of the treatment 3. Breastfeeding Individuals who are breastfeeding as this population is not considered for phage treatment due to unknown risk to the infant

Outcomes

Primary Outcomes

Biomarkers associated with clinical and/or radiographic improvement and/or culture improvement

Improvement 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.

Time frame: End of study (up to 2 years)

Secondary Outcomes

Biomarkers associated with the development of neutralization antibodies

Time frame: End of study (up to 2 years)

Central Contacts

Doreen Addrizzo-Harris, MD, FCCP

CONTACT

212-263-6479 Doreen.Addrizzo@nyulangone.org

Lira Gutierrez