NCT07076238 · NYU Langone Health
Biomarkers of Phage Treatment Response in NTM and Other Infections
What this study is about
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.
View original scientific description
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.
Interventions
BIOLOGICAL
Bacteriophage Treatment
Participants who have a positive match for their NTM isolate will start on mycobacteriophage treatment per prescribed treatment regimen.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 30, 2025 · Source of record for eligibility and locations