Programs and studies

Clinical study

POSTSTAMP

Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria

StatusInvitation only
TypeObservational study
CountriesUnited States
Conditions studiedCystic Fibrosis; Nontuberculous Mycobacterial Lung Disease; Nontuberculous Mycobacterium Infection; Mycobacterium Infections; Mycobacterium; Pulmonary
Study years2024–2028 (estimated)
Entry review2026-10-03

Participation

Check the study record or contact the study team for current recruitment and eligibility.

Study eligibility

Inclusion Criteria: 1. Written informed consent (and assent when applicable) obtained from participant or participant's legal representative 2. Enrolled in the CFF Patient Registry (CFF PR) 3. Be willing to adhere to study procedures in the context of clinical care, and other protocol requirements 4. 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) 5. Diagnosis of CF consistent with the 2017 CFF Guidelines 6. NTM pulmonary disease on treatment with guideline-based antibiotics for \>12 months without consistent conversion of airway cultures to negative. 7. Physician intention to treat NTM with phage therapy (if susceptible) 8. Be willing and able to continue guideline-based antibiotics for NTM concurrent with phage. 9. 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. Exclusion Criteria: 1. Pregnant or breastfeeding 2. Prior or ongoing phage therapy for the species of NTM under consideration. 3. History of solid organ or hematological transplantation 4. 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

Study description

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.

Study registrations

ClinicalTrials.govNCT06262282
Recorded study locations (18)

Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.

University of Alabama

Birmingham, Alabama, United States

Recorded site status: Not separately listed. Study location source ↗

Children's Hospital of Los Angeles

Los Angeles, California, United States

Recorded site status: Not separately listed. Study location source ↗

University of California

San Diego, California, United States

Recorded site status: Not separately listed. Study location source ↗

Childrens Hospital Colorado

Denver, Colorado, United States

Recorded site status: Not separately listed. Study location source ↗

National Jewish Health

Denver, Colorado, United States

Recorded site status: Not separately listed. Study location source ↗

University of Florida

Gainesville, Florida, United States

Recorded site status: Not separately listed. Study location source ↗

Northwestern University

Chicago, Illinois, United States

Recorded site status: Not separately listed. Study location source ↗

John Hopkins University

Baltimore, Maryland, United States

Recorded site status: Not separately listed. Study location source ↗

Boston Childrens Hospital

Boston, Massachusetts, United States

Recorded site status: Not separately listed. Study location source ↗

University of Michigan

Ann Arbor, Michigan, United States

Recorded site status: Not separately listed. Study location source ↗

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Recorded site status: Not separately listed. Study location source ↗

Columbia University

New York, New York, United States

Recorded site status: Not separately listed. Study location source ↗

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Recorded site status: Not separately listed. Study location source ↗

Nationwide Children's Hospital

Columbus, Ohio, United States

Recorded site status: Not separately listed. Study location source ↗

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Recorded site status: Not separately listed. Study location source ↗

Southwestern Medical Center at Dallas

Dallas, Texas, United States

Recorded site status: Not separately listed. Study location source ↗

University of Vermont

Burlington, Vermont, United States

Recorded site status: Not separately listed. Study location source ↗

University of Washington

Seattle, Washington, United States

Recorded site status: Not separately listed. Study location source ↗

Related programs(1)

Sources and updates

Entry reviewed . This is the date of our source review, not a confirmation of availability today.

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Study ID
nct06262282