RECRUITING

Biomarkers of Phage Treatment Response in NTM and Other Infections

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-25
Study Completion:2032-06-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07076238

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults 18 years of age or older
  2. 2. Provision of appropriate written consent
  3. 3. Willingness and ability to participate in study procedures
  4. 4. Diagnosis of bacterial/mycobacterial infection that meets criteria for treatment (clinical, radiographic, and microbiologic data)
  5. 5. Patients are being considered by clinician for phage therapy as a part of their standard of care
  1. 1. Patients under 18 years of age
  2. 2. Pregnant individuals as this population is not considered for phage treatment due to unknown risks of the treatment
  3. 3. Breastfeeding Individuals who are breastfeeding as this population is not considered for phage treatment due to unknown risk to the infant

Contacts and Locations

Study Contact

Doreen Addrizzo-Harris, MD, FCCP
CONTACT
212-263-6479
Doreen.Addrizzo@nyulangone.org
Lira Gutierrez
CONTACT
347-306-4168
Lira.Gutierrez@nyulangone.org

Principal Investigator

Doreen Addrizzo-Harris, MD, FCCP
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Doreen Addrizzo-Harris, MD, FCCP, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-25
Study Completion Date2032-06-25

Study Record Updates

Study Start Date2025-06-25
Study Completion Date2032-06-25

Terms related to this study

Keywords Provided by Researchers

  • Bacteriophage therapy
  • Refractory bacterial infection

Additional Relevant MeSH Terms

  • Nontuberculous Mycobacterial Lung Disease