Biomarkers of Phage Treatment Response in NTM and Other Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bacteriophage Treatment.
- Who it may be relevant to
- Registry conditions: Nontuberculous Mycobacterial Lung Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-Center Observational Biomarker Investigation of Response to Bacteriophage Treatment for Bacterial Infection
Overview
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.
Interventions
- Biological Bacteriophage Treatment
Participants who have a positive match for their NTM isolate will start on mycobacteriophage treatment per prescribed treatment regimen.
Primary outcome measures
- Biomarkers associated with clinical and/or radiographic improvement and/or culture improvement [Time frame: End of study (up to 2 years)]
Secondary outcome measures (1)
- Biomarkers associated with the development of neutralization antibodies [Time frame: End of study (up to 2 years)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07076238 · 25-00062