Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Jewish Health
Study ID
NCT06262282
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 5, 2024
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
10 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Adherence to therapy [ Time Frame: Comparing the year of phage therapy to the year prior to start of phage therapy ]

Locations (18)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35233-
Children's Hospital of Los AngelesLos AngelesCalifornia90027-
University of CaliforniaSan DiegoCalifornia92103-
Childrens Hospital ColoradoDenverColorado80045-
National Jewish HealthDenverColorado80206-
University of FloridaGainesvilleFlorida32610-
Northwestern UniversityChicagoIllinois60611-
John Hopkins UniversityBaltimoreMaryland21218-
Boston Childrens HospitalBostonMassachusetts02115-
University of MichiganAnn ArborMichigan48109-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
Columbia UniversityNew YorkNew York10032-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Nationwide Children's HospitalColumbusOhio43215-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Southwestern Medical Center at DallasDallasTexas75390-
University of VermontBurlingtonVermont05401-
University of WashingtonSeattleWashington98195-

Find similar trials in Birmingham, AL

By research site
University of Alabama· Birmingham, ALChildren's Hospital of Los Angeles· Los Angeles, CAUniversity of California· San Diego, CAChildrens Hospital Colorado· Denver, CONational Jewish Health· Denver, COUniversity of Florida· Gainesville, FL

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