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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacteriophage Treatment | Biological | Participants who have a positive match for their NTM isolate will start on mycobacteriophage treatment per prescribed treatment regimen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of study (up to 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers associated with the development of neutralization antibodies | End of study (up to 2 years) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doreen Addrizzo-Harris, MD, FCCP | Contact | 212-263-6479 | Doreen.Addrizzo@nyulangone.org | |
| Lira Gutierrez | Contact | 347-306-4168 | Lira.Gutierrez@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Doreen Addrizzo-Harris, MD, FCCP | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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.
Beginning 3 months and ending 5 years following article publication
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Doreen.Addrizzo@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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Blood samples, sputum samples, and oral rinse samples