Biomarkers of Phage Treatment Response in NTM and Other Infections

NYU Langone Health

Status: Enrolling

Conditions: Nontuberculous Mycobacterial Lung Disease

Treatments: Biological: Bacteriophage Treatment

Study type: Observational

Funder types: Other

Identifiers

NCT07076238

25-00062

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Participants receiving phage therapy

Description:

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.

Treatment:

Biological: Bacteriophage Treatment

Participants not receiving phage therapy

Description:

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.