An observational study in Cystic Fibrosis, Nontuberculous Mycobacterial Lung Disease and Nontuberculous Mycobacterium Infection, sponsored by National Jewish Health. Enrolling by invitation at 18 sites in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by National Jewish Health · Observational
About 10 people with cystic fibrosis (CF) and persistent Nontuberculosis mycobacteria (NTM) infection despite treatment will be screened to find out if their NTM infection has at least one mycobacteriophage that is effective in killing the mycobacteria. Individuals who are found to have at least one phage will be offered assistance in pursuing FDA approval for treatment via expanded-access Individual New Drug (IND) for compassionate-use. They will receive phage treatment for 1 year along with their guideline-based antibiotics for NTM. Individuals who are not identified as having a phage match will be followed as they continue to receive guideline based antibiotic therapy for 1 year. All subjects, including those who do not have a phage match will continue to be observed for the duration of the study, or about 1 year.
About 10 people with cystic fibrosis and NTM infection with positive sputum cultures after a minimum of 12 months of guideline-based therapy will be screened to find out if their NTM infection has at least one mycobacteriophage that is known to be effective against the NTM. Individuals who have been found to have at least one effective phage will be offered assistance in pursuing FDA approval for phage treatment through a compassionate-use Individual New Drug (IND). These subjects will receive phage treatment for 1 year along with their guideline-based antibiotics for NTM. Individuals who are not identified as having a phage match will continue to receive guideline based antibiotic therapy. All subjects, receiving phage or not, will be observed and assessed, including collection of specimens, to evaluate response to treatment.
1,619 studies on the registry are indexed under Cystic Fibrosis; 199 are open to participants now.
This study's planned enrollment of 10 is below the median of 85 across 503 observational studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →National Jewish Health is the lead sponsor of 109 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants with a diagnosis of CF who meet all of the inclusion and none of the exclusion criteria will be eligible for participation in this study.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
People with cystic fibrosis who have identified at least one phage effective against their NTM infection and are receiving treatment with the phage. These subjects will remain on guideline based NTM antibiotic treatment and their standard CF care. They will receive therapeutic phage twice daily for 1 year.
Biological: mycobacteriophage
People with cystic fibrosis who have not identified any phage effective against their NTM infection and are not receiving phage treatment. These subjects will continue with guideline based NTM antibiotic treatment for their NTM disease and standard CF care.
mycobacteriophage phage that has been found effective in killing participants NTM infection
Adherence to therapy
Proportion who adhere to the POSTSTAMP protocol based on number of respiratory cultures obtained per year, withdrawals or major deviations from protocol.
Time frame: Comparing the year of phage therapy to the year prior to start of phage therapy
Phage susceptibility
Proportion of participants with NTM infection susceptible to phage
Time frame: At the time of enrollment
Culture conversion
Proportion of participants with \>12 months of consecutive negative cultures with no subsequent positive cultures.
Time frame: Any 12 month interval from the start of phage therapy to end of follow-up, an average of about 2 years.
Tolerance of treatment
Proportion requiring antibiotic course change due to intolerance or lack of microbiological conversion (i.e. eradication from sputum)
Time frame: From enrollment through study completion, an average of about 24-30 months.
Clinical Response (pulmonary function testing)
Within subject change in forced expiratory volume at one second (FEV1) with increase indicating improvement in lung function or FEV1 decrease indicating decline in lung function.
Time frame: From enrollment through study completion, an average of about 24-30 months.
Microbiologic response to phage
Within-subject change in percent positive (%pos) cultures following phage initiation (or identification that no phage is available), compared to the interval prior to phage initiation (or identification that no phage is available): the period of antibiotic treatment without phage.
Time frame: A year interval from month 6 of treatment to month 18 following start of phage will be compared to the year prior to start of phage.
Clinical response (BMI)
Within subject change in BMI with decline in BMI as sign of decline or worse outcome.
Time frame: From enrollment through study completion, an average of about 24-30 months.
Clinical response (CFQR)
Within subject change in Cystic Fibrosis Questionnaire -Research (CFQR) score, with higher score indicating worse symptoms.
Time frame: From enrollment through study completion, an average of about 24-30 months.
Clinical Response (antibiotic courses for non- NTM exacerbations)
Proportion of non-NTM exacerbations compared to NTM exacerbations.
Time frame: From enrollment through study completion, an average of about 24-30 months.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Dec 2026, 34 months after the start.
Of 228 non-industry observational studies under Cystic Fibrosis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 89. This study's planned 34 months is below that.
Counting every sponsor, half of 243 studies reached it within 41 months; a quarter within 19 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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