Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria
POSTSTAMP
A Prospective Standardized Assessment of People With Cystic Fibrosis and Non-tuberculosis Mycobacteria Pulmonary Disease Undergoing Treatment With Mycobacteriophage (POSTSTAMP)
1 other identifier
observational
10
1 country
18
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2024
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2024
CompletedStudy Start
First participant enrolled
February 5, 2024
CompletedFirst Posted
Study publicly available on registry
February 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
May 21, 2025
May 1, 2025
2.9 years
February 4, 2024
May 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Comparing the year of phage therapy to the year prior to start of phage therapy
Secondary Outcomes (8)
Phage susceptibility
At the time of enrollment
Culture conversion
Any 12 month interval from the start of phage therapy to end of follow-up, an average of about 2 years.
Tolerance of treatment
From enrollment through study completion, an average of about 24-30 months.
Clinical Response (pulmonary function testing)
From enrollment through study completion, an average of about 24-30 months.
Microbiologic response to phage
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.
- +3 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
mycobacteriophage phage that has been found effective in killing participants NTM infection
Eligibility Criteria
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.
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Jewish Healthlead
- Cystic Fibrosis Foundationcollaborator
Study Sites (18)
University of Alabama
Birmingham, Alabama, 35233, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California
San Diego, California, 92103, United States
Childrens Hospital Colorado
Denver, Colorado, 80045, United States
National Jewish Health
Denver, Colorado, 80206, United States
University of Florida
Gainesville, Florida, 32610, United States
Northwestern University
Chicago, Illinois, 60611, United States
John Hopkins University
Baltimore, Maryland, 21218, United States
Boston Childrens Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Columbia University
New York, New York, 10032, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Nationwide Children's Hospital
Columbus, Ohio, 43215, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
University of Vermont
Burlington, Vermont, 05401, United States
University of Washington
Seattle, Washington, 98195, United States
Biospecimen
NTM isolates will be sent to the National Jewish Health (NJH) laboratory for additional testing and will be stored for future research. Specimens will be banked for future research use (blood, sputum, urine, and NTM isolates- including any previous isolates that might be available or previously sent to NJH for analysis). The specimens will be used to learn more about NTM Disease and to learn more about CF.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jerry Nick, MD
National Jewish Health
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Adult Cystic Fibrosis Program
Study Record Dates
First Submitted
February 4, 2024
First Posted
February 16, 2024
Study Start
February 5, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2028
Last Updated
May 21, 2025
Record last verified: 2025-05