Nontuberculous Mycobacterial Lung DiseaseNCT07076238
Biomarkers of Phage Treatment Response in NTM and Other Infections
An observational study of Nontuberculous Mycobacterial Lung Disease, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nontuberculous Mycobacterial Lung Disease
- What is being tested?
- Bacteriophage Treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2025to 25 Jun 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Nontuberculous Mycobacterial (NTM) disease who are considered for treatment with phage therapy will be recruited. Those that have a positive match for their NTM isolate and starts on mycobacteriophage treatment will be considered cases while those that do not have a positive match and/or does not start on mycobacteriophage treatment will be considered controls.
Who may be able to join
- Adults 18 years of age or older
- Provision of appropriate written consent
- Willingness and ability to participate in study procedures
- Diagnosis of bacterial/mycobacterial infection that meets criteria for treatment (clinical, radiographic, and microbiologic data)
- Patients are being considered by clinician for phage therapy as a part of their standard of care
Who cannot join
- Patients under 18 years of age
- Pregnant individuals as this population is not considered for phage treatment due to unknown risks of the treatment
- Breastfeeding Individuals who are breastfeeding as this population is not considered for phage treatment due to unknown risk to the infant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: A Single-Center Observational Biomarker Investigation of Response to Bacteriophage Treatment for Bacterial Infection
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.
- Being tested
- Bacteriophage Treatment
- Keywords
- Bacteriophage therapy, Refractory bacterial infection
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacteriophage TreatmentBiological
Participants who have a positive match for their NTM isolate will start on mycobacteriophage treatment per prescribed treatment regimen.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving phage therapy | Participants who have a positive match for their Nontuberculous Mycobacterial (NTM) isolate will start on mycobacteriophage treatment. Blood and leftover and/or discarded airway samples will be obtained from follow up visits of patients. Receives: Biological: Bacteriophage Treatment | |
| Participants not receiving phage therapy | Participants who don't have a positive match and/or do not start on mycobacteriophage treatment. Blood and leftover and/or discarded airway samples will be obtained from follow up visits of patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers associated with clinical and/or radiographic improvement and/or culture improvement
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.
Measured: End of study (up to 2 years)
Secondary outcomes (1)
Biomarkers associated with the development of neutralization antibodies
Measured: End of study (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start25 Jun 2025
- Primary completion25 Jun 2030 (estimated)
- Study completion25 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nontuberculous Mycobacterial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doreen Addrizzo-Harris, MD, FCCP, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076238
- Sponsor's protocol ID
- 25-00062
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 3 months and ending 5 years following article publication, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Doreen.Addrizzo@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.