Biomarkers of Phage Treatment Response in NTM and Other Infections

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

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 Overview

• Status: Recruiting
• Conditions: Nontuberculous Mycobacterial Lung Disease
• Intervention / Treatment: Biological: Bacteriophage Treatment

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Doreen Addrizzo-Harris, MD, FCCP; Phone Number: 212-263-6479; Email: Doreen.Addrizzo@nyulangone.org
• Study Contact Backup: Name: Lira Gutierrez; Phone Number: 347-306-4168; Email: Lira.Gutierrez@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 who have a positive match for their NTM isolate will start on mycobacteriophage treatment per prescribed treatment regimen.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Biomarkers associated with the development of neutralization antibodies	End of study (up to 2 years)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Doreen Addrizzo-Harris, MD, FCCP, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2025
• Primary Completion (Estimated): June 25, 2030
• Study Completion (Estimated): June 25, 2032

Study Registration Dates

• First Submitted: July 14, 2025
• First Submitted That Met QC Criteria: July 14, 2025
• First Posted (Actual): July 22, 2025

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Bacteriophage therapy; Refractory bacterial infection
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: 25-00062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 3 months and ending 5 years following article publication, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Doreen.Addrizzo@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No