An observational study in Nontuberculous Mycobacterial Lung Disease, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by NYU Langone Health · Observational
Among 181 studies in Bacterial Infections with a site in United States — 12 open to participants now, 15 under way, 2 of them phase 3. Bacterial Infections · United States.
Among the 181 studies in Bacterial Infections with a site in United States, this one is the 17th largest by planned enrollment of the 29 observational ones that give a count, is one of 6 that started in 2025, is one of 29 observational ones, reaches primary completion later than 13 of the 14 other live ones, and was the 175th registered.
584 studies on the registry are indexed under Bacterial Infections; 84 are open to participants now.
Browse Bacterial Infections studies →12 of the 181 studies in Bacterial Infections with a site in United States are open now. Recruiting first, the newest first:
Nanopath, Inc · Sites in United States
Bausch Health Americas, Inc. · Sites in United States
Karius, Inc. · Sites in United States
Baxis Pharmaceuticals, Inc. · Sites in United States
The University of Texas Health Science Center, Houston · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 56 Bacterial Infections studies recruiting now, 37 (66%) set no upper age limit and 14 (25%) stop at 75 or younger; 19 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
181 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 67 · Phase 2 27 · Phase 3 24 · Phase 4 15
First in 1997; this study’s year is marked. 6 started in 2025.
This study's planned enrollment of 100 is below the median of 200 across 185 observational studies indexed under Bacterial Infections.
Median enrollment 62 across the 151 interventional studies, 200 across the 29 observational. Of the 160 that completed or were terminated, 58 (36%) have results posted.
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102 of 181 have an industry lead sponsor. The 10 most frequent:
NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
NYU Langone Health has 2 studies filed under Bacterial Infections — fewer than ten, so there is no comparison to draw.
7 of the studies in Bacterial Infections with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07607470Nanopath, IncLarge Algorithm Setting and Validation Study | 2026-12 |
| NCT06070688The University of Texas Health Science Center, HoustonAn Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED. | 2026-12-31 |
| NCT07285785Bausch Health Americas, Inc.Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea | 2027-04-20 |
| NCT05846399University of Missouri-ColumbiaCAT BITE Antibiotic Prophylaxis for the Hand/Forearm (CATBITE) | 2027-07-01 |
| NCT07371429GlaxoSmithKlineA Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics | 2027-08-23 |
Among the 181 studies in Bacterial Infections with a site in United States, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Biological: Bacteriophage Treatment
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.
Participants who have a positive match for their NTM isolate will start on mycobacteriophage treatment per prescribed treatment regimen.
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.
Time frame: End of study (up to 2 years)
Biomarkers associated with the development of neutralization antibodies
Time frame: End of study (up to 2 years)
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 3 months and ending 5 years following article publication
Access criteria: 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.
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Jun 2030, 60 months after the start.
Of 73 non-industry observational studies under Bacterial Infections, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 60 months is above that.
Counting every sponsor, half of 80 studies reached it within 22 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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