Biomarkers of Phage Treatment Response in NTM and Other Infections

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07076238
Status
Recruiting
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Conditions

  • Nontuberculous Mycobacterial Lung Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bacteriophage Treatment — BIOLOGICAL
    Participants who have a positive match for their NTM isolate will start on mycobacteriophage treatment per prescribed treatment regimen.

Study Details

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.

Key Dates

Start date
Jun 25, 2025
Status verified
Oct 2025
Primary completion
Jun 25, 2030
Completion
Jun 25, 2032

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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