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Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria

NCT06262282 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2025-05-21

No results posted yet for this study

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.

Conditions

  • Cystic Fibrosis
  • Nontuberculous Mycobacterial Lung Disease
  • Nontuberculous Mycobacterium Infection
  • Mycobacterium Infections
  • Mycobacterium; Pulmonary

Interventions

BIOLOGICAL

mycobacteriophage

mycobacteriophage phage that has been found effective in killing participants NTM infection

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • National Jewish Health

    lead OTHER

Principal Investigators

  • Jerry Nick, MD · National Jewish Health

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-05
Primary Completion
2026-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06262282 on ClinicalTrials.gov