Nontuberculous Mycobacterial Lung Disease
Conditions
Keywords
Bacteriophage therapy, Refractory bacterial infection
Brief summary
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
BIOLOGICALBacteriophage Treatment
Participants who have a positive match for their NTM isolate will start on mycobacteriophage treatment per prescribed treatment regimen.
Sponsors
NYU Langone Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/mycobacterial 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers associated with clinical and/or radiographic improvement and/or culture improvement | 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
| Measure | Time frame |
|---|---|
| Biomarkers associated with the development of neutralization antibodies | End of study (up to 2 years) |
Countries
United States
Contacts
CONTACTDoreen Addrizzo-Harris, MD, FCCP
CONTACTLira Gutierrez
PRINCIPAL_INVESTIGATORDoreen Addrizzo-Harris, MD, FCCP
NYU Langone Health
Outcome results
None listed