NCT07076238 Biomarkers of Phage Treatment Response in NTM and Other Infections
| NCT ID | NCT07076238 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Nontuberculous Mycobacterial Lung Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-06-25 |
| Primary Completion | 2030-06-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-06-25 with a primary completion date of 2030-06-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Doreen Addrizzo-Harris, MD, FCCP
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT07076238 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nontuberculous Mycobacterial Lung Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07076238 currently recruiting?
Yes, NCT07076238 is actively recruiting participants. Contact the research team at Doreen.Addrizzo@nyulangone.org for enrollment information.
Where is the NCT07076238 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07076238 clinical trial?
NCT07076238 is sponsored by NYU Langone Health. The principal investigator is Doreen Addrizzo-Harris, MD, FCCP at NYU Langone Health. The trial plans to enroll 100 participants.