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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Observational
SUMMARY

This study aims to identify biomarkers associated with response to phage therapy for refractory bacterial infections. Blood and leftover and/or discarded 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 neutralizing antibody against phages, inflammatory cytokines, transcriptome and microbiome. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults 18 years of age or older

• Provision of appropriate written consent

• Willingness and ability to participate in study procedures

• Diagnosis of bacterial 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

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Doreen Addrizzo-Harris, MD, FCCP
Doreen.Addrizzo@nyulangone.org
212-263-6479
Backup
Lira Gutierrez
Lira.Gutierrez@nyulangone.org
347-306-4168
Time Frame
Start Date: 2025-06-25
Estimated Completion Date: 2032-06-25
Participants
Target number of participants: 100
Treatments
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.
Sponsors
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov