Recruiting

Phage Therapy

Sponsor:

NYU Langone Health

Code:

NCT07076238

Conditions

Nontuberculous Mycobacterial Lung Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bacteriophage Treatment

Study Details

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

Study ID

NCT07076238

Start date

Jun 25, 2025

Status verified date

Aug, 2026

Completion date

Jun 25, 2032

Anticipated

Primary completion date

Jun 25, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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

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

Primary outcome measure

  • Biomarkers associated with clinical and/or radiographic improvement and/or culture improvement [ Time Frame: End of study (up to 2 years) ]

Central Contacts and Locations

Central contacts

Doreen Addrizzo-Harris, MD, FCCP

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

Lira Gutierrez

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

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Bacteriophage therapy
  • Refractory bacterial infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-09-01.