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

Description

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.

Conditions

Nontuberculous Mycobacterial Lung Disease
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Related Conditions:

Nontuberculous Mycobacterial Lung Disease

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Nontuberculous Mycobacterial Lung Disease
Intervention / Treatment

-

Contacts and Locations

New York

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NYU Langone Health,

Leopoldo N. Segal, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

2032-06-25