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Recruiting NCT07076238

Biomarkers of Phage Treatment Response in NTM and Other Infections

Conditions: Nontuberculous Mycobacterial Lung Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: NYU Langone Health

Location: NYU Langone Health New York New York

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07076238). StuddyBuddy aggregates publicly available trial information.