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NCT Number: NCT07076238

Biomarkers of Phage Treatment Response in NTM and Other Infections

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.

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Key information

Conditions

Nontuberculous Mycobacterial Lung Disease Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Bacteriophage Treatment

Biological

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

Primary outcomes

  1. Biomarkers associated with clinical and/or radiographic improvement and/or culture improvement

    Time frame: End of study (up to 2 years)

    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.

Secondary outcomes

  1. Biomarkers associated with the development of neutralization antibodies

    Time frame: End of study (up to 2 years)

Study contacts

Contact information is provided by the study sponsor or research team.

Doreen Addrizzo-Harris, MD, FCCP

CONTACT

[email protected]

212-263-6479

Lira Gutierrez

CONTACT

[email protected]

347-306-4168

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2032
First posted
Jul 22, 2025
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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