Biomarkers linked to response to phage treatment for nontuberculous mycobacterial and other infections
A Single-Center Observational Biomarker Investigation of Response to Bacteriophage Treatment for Bacterial Infection
NYU Langone Health · NCT07076238
This project will test whether blood and airway biomarkers can show which adults with refractory nontuberculous mycobacterial or other bacterial infections respond to bacteriophage treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07076238 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18+) with confirmed bacterial or nontuberculous mycobacterial infections who are being considered by their clinician for phage therapy and can provide consent and attend study visits are ideal candidates.
Not a fit: Pregnant or breastfeeding individuals, patients under 18, and people whose infections are not being considered for phage therapy are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help predict which patients are likely to benefit from phage therapy and guide treatment decisions.
How similar studies have performed: Case reports and small series have shown promising results for phage therapy in refractory bacterial infections, but using biomarkers to predict response remains largely untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nontuberculous Mycobacterial Lung Disease, Bacteriophage therapy, Refractory bacterial infection