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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Observational Biomarker Investigation of Response to Bacteriophage Treatment for Bacterial Infection
- ClinicalTrials.gov ID
- NCT07076238
- Acronym / sponsor ID
- 25-00062
- Keywords
- Bacteriophage therapy, Refractory bacterial infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 25 Jun 2030 (estimated)
- Study completion
- 25 Jun 2032 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants receiving phage therapy | – | Biological: Bacteriophage TreatmentParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacteriophage TreatmentParticipants who have a positive match for their NTM isolate will start on mycobacteriophage treatment per prescribed treatment regimen. | Biological | Participants receiving phage therapy |
Primary outcome
Biomarkers associated with clinical and/or radiographic improvement and/or culture improvement
Time frame: End of study (up to 2 years)
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.
1 secondary outcome
Biomarkers associated with the development of neutralization antibodies
Time frame: End of study (up to 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Doreen Addrizzo-Harris, MD, FCCP principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nontuberculous Mycobacterial Lung Disease, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doreen Addrizzo-Harris, MD, FCCP (212-263-6479, Doreen.Addrizzo@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers associated with clinical and/or radiographic improvement and/or culture improvement (time frame: End of study (up to 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.