Biomarkers linked to response to phage treatment for nontuberculous mycobacterial and other infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study enrolling adults with bacterial or mycobacterial infections who are being considered for bacteriophage therapy. Blood and airway samples will be collected at follow-up visits and analyzed for changes in the airway microbiome, host transcriptome, inflammatory cytokines, and development of neutralizing antibodies to phages. Samples from patients who receive phage therapy will be compared with samples from those who do not receive phage therapy. The primary goal is to identify biomarkers associated with clinical, radiographic, or culture improvement after at least 6–8 weeks of bacteriophage treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Doreen Addrizzo-Harris, MD, FCCP — NYU Langone Health
• Study coordinator: Doreen Addrizzo-Harris, MD, FCCP
• Email: Doreen.Addrizzo@nyulangone.org
• Phone: 212-263-6479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.