Cystic FibrosisPOSTSTAMPNCT06262282
Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria
An observational study of Cystic Fibrosis and Nontuberculous Mycobacterial Lung Disease, run by National Jewish Health at 18 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis, Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterium Infection
- What is being tested?
- mycobacteriophage
- How many people
- 10 participants
- Where
- 18 sitesUnited States
- Study dates
- 5 Feb 2024to 31 Dec 2028
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Written informed consent (and assent when applicable) obtained from participant or participant's legal representative
- Enrolled in the CFF Patient Registry (CFF PR)
- Be willing to adhere to study procedures in the context of clinical care, and other protocol requirements
- Male or female participant ≥ 6 years of age at enrollment who are able to reliably expectorate sputum and/or willing to undergo sputum induction (if necessary)
- Diagnosis of CF consistent with the 2017 CFF Guidelines
- NTM pulmonary disease on treatment with guideline-based antibiotics for >12 months without consistent conversion of airway cultures to negative.
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- Physician intention to treat NTM with phage therapy (if susceptible)
- Be willing and able to continue guideline-based antibiotics for NTM concurrent with phage.
- Documentation of a sufficient number of NTM cultures with a sufficient proportion of positive cultures in the interval 12 months prior to initiation of phage to allow for a within-subject power ≥0.80 to detect a difference in the percent positive NTM cultures in the interval 6-18 months following initiation of phage.
Who cannot join
- Pregnant or breastfeeding
- Prior or ongoing phage therapy for the species of NTM under consideration.
- History of solid organ or hematological transplantation
- Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites
University of Michigan
Ann Arbor, Michigan, 48109
John Hopkins University
Baltimore, Maryland, 21218
University of Alabama
Birmingham, Alabama, 35233
Boston Childrens Hospital
Boston, Massachusetts, 02115
University of Vermont
Burlington, Vermont, 05401
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Northwestern University
Chicago, Illinois, 60611
Nationwide Children's Hospital
Columbus, Ohio, 43215
Southwestern Medical Center at Dallas
Dallas, Texas, 75390
Childrens Hospital Colorado
Denver, Colorado, 80045
National Jewish Health
Denver, Colorado, 80206
University of Florida
Gainesville, Florida, 32610
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Columbia University
New York, New York, 10032
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of California
San Diego, California, 92103
University of Washington
Seattle, Washington, 98195
About this study
Official title: A Prospective Standardized Assessment of People With Cystic Fibrosis and Non-tuberculosis Mycobacteria Pulmonary Disease Undergoing Treatment With Mycobacteriophage (POSTSTAMP)
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.
Read the detailed description
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.
- Conditions
- Cystic Fibrosis, Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterium Infection, Mycobacterium Infections, Mycobacterium; Pulmonary
- Being tested
- mycobacteriophage
- Keywords
- cystic fibrosis, phage, mycobacteriophage
- Medical subject headings
- Cystic Fibrosis, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mycobacteriophageBiological
mycobacteriophage phage that has been found effective in killing participants NTM infection
| Study group | Role | What they receive |
|---|---|---|
| People with cystic fibrosis who are receiving phage treatment for NTM. | 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. Receives: Biological: mycobacteriophage | |
| People with cystic fibrosis who are not receiving phage treatment for NTM. | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Comparing the year of phage therapy to the year prior to start of phage therapy
Secondary outcomes (8)
Phage susceptibility
Proportion of participants with NTM infection susceptible to phage
Measured: At the time of enrollment
Culture conversion
Proportion of participants with >12 months of consecutive negative cultures with no subsequent positive cultures.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment through study completion, an average of about 24-30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start5 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Principal investigator, Jerry A. Nick, M.D., National Jewish Health
- Investigators
- Jerry Nick, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262282
- Sponsor's protocol ID
- NTM-OB-17 (PART C)
- Acronym
- POSTSTAMP
- Status last verified
- May 2025
- First submitted
- 4 Feb 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Standardized Assessment of People With Cystic Fibrosis and Non-tuberculosis Mycobacteria Pulmonary Disease Undergoing Treatment With Mycobacteriophage (POSTSTAMP)
- ClinicalTrials.gov ID
- NCT06262282
- Acronym / sponsor ID
- POSTSTAMP / NTM-OB-17 (PART C)
- Conditions
- Cystic Fibrosis, Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterium Infection, Mycobacterium Infections, Mycobacterium; Pulmonary
- Keywords
- cystic fibrosis, phage, mycobacteriophage
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Feb 2024 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with cystic fibrosis who are receiving phage treatment for NTM. | – | Biological: mycobacteriophagePeople 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. |
| People with cystic fibrosis who are not receiving phage treatment for NTM. | – | –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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- Written informed consent (and assent when applicable) obtained from participant or participant's legal representative
- Enrolled in the CFF Patient Registry (CFF PR)
- Be willing to adhere to study procedures in the context of clinical care, and other protocol requirements
- Male or female participant ≥ 6 years of age at enrollment who are able to reliably expectorate sputum and/or willing to undergo sputum induction (if necessary)
- Diagnosis of CF consistent with the 2017 CFF Guidelines
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding
- Prior or ongoing phage therapy for the species of NTM under consideration.
- History of solid organ or hematological transplantation
- Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
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 |
|---|---|---|
| mycobacteriophagemycobacteriophage phage that has been found effective in killing participants NTM infection | Biological | People with cystic fibrosis who are receiving phage treatment for NTM. |
Primary outcome
Adherence to therapy
Time frame: Comparing the year of phage therapy to the year prior to start of phage therapy
Proportion who adhere to the POSTSTAMP protocol based on number of respiratory cultures obtained per year, withdrawals or major deviations from protocol.
8 secondary outcomes
Phage susceptibility
Time frame: At the time of enrollment
Culture conversion
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
Time frame: From enrollment through study completion, an average of about 24-30 months.
Clinical Response (pulmonary function testing)
Time frame: From enrollment through study completion, an average of about 24-30 months.
Microbiologic response to 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)
Time frame: From enrollment through study completion, an average of about 24-30 months.
Clinical response (CFQR)
Time frame: From enrollment through study completion, an average of about 24-30 months.
Clinical Response (antibiotic courses for non- NTM exacerbations)
Time frame: From enrollment through study completion, an average of about 24-30 months.
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 21 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Jerry Nick, MD principal investigator
National Jewish Health
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Nontuberculous Mycobacterial Lung Disease, run by National Jewish Health at 18 sites 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 9 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to therapy (time frame: Comparing the year of phage therapy to the year prior to start of phage therapy). 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 21 May 2025.