Biomarkers of Phage Treatment Response in NTM and Other Infections

NCT07076238 | Recruiting

• 1 other identifier: 25-00062
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bacteriophage therapy; Refractory bacterial infection

Outcome Measures

Primary Outcomes (1)

• 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.

  End of study (up to 2 years)

Secondary Outcomes (1)

• Biomarkers associated with the development of neutralization antibodies

  End of study (up to 2 years)

Study Arms (2)

Participants receiving phage therapy

Participants who have a positive match for their Nontuberculous Mycobacterial (NTM) isolate will start on mycobacteriophage treatment. Blood and leftover and/or discarded airway samples will be obtained from follow up visits of patients.

Biological: Bacteriophage Treatment

Participants not receiving phage therapy

Participants who don't have a positive match and/or do not start on mycobacteriophage treatment. Blood and leftover and/or discarded airway samples will be obtained from follow up visits of patients.

Interventions

Bacteriophage Treatment BIOLOGICAL

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

Participants receiving phage therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Nontuberculous Mycobacterial (NTM) disease who are considered for treatment with phage therapy will be recruited. Those that have a positive match for their NTM isolate and starts on mycobacteriophage treatment will be considered cases while those that do not have a positive match and/or does not start on mycobacteriophage treatment will be considered controls.

You may qualify if:

• Adults 18 years of age or older
• Provision of appropriate written consent
• Willingness and ability to participate in study procedures
• Diagnosis of bacterial/mycobacterial infection that meets criteria for treatment (clinical, radiographic, and microbiologic data)
• Patients are being considered by clinician for phage therapy as a part of their standard of care

You may not qualify if:

• Patients under 18 years of age
• Pregnant individuals as this population is not considered for phage treatment due to unknown risks of the treatment
• Breastfeeding Individuals who are breastfeeding as this population is not considered for phage treatment due to unknown risk to the infant

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples, sputum samples, and oral rinse samples

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Doreen Addrizzo-Harris, MD, FCCP

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doreen Addrizzo-Harris, MD, FCCP

CONTACT

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

Lira Gutierrez

CONTACT

347-306-4168; Lira.Gutierrez@nyulangone.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 22, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): June 25, 2030
• Study Completion (Estimated): June 25, 2032
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Doreen.Addrizzo@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

Locations

US (1)