Prospective Healthcare-Associated Links in Transmission of Nontuberculous Mycobacteria

Part of paid clinical trials in Denver, Colorado.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT05686837
Status
Enrolling By Invitation

Conditions

  • Cystic Fibrosis
  • Nontuberculous Mycobacterial Pulmonary Infection

Eligibility Criteria

Sex
ALL
Age
1 Month - 99 Years
Healthy Volunteers
Not accepted

Study Details

Pulmonary NTM infection is recognized as one of the most challenging infections to treat among people with cystic fibrosis (PwCF), notable for prolonged treatment courses and often poor response to therapy. Positive cultures for NTM occur in about 20% of children and adults with cystic fibrosis (CF). However, the source of NTM infection, modes of transmission, and exposure risks are poorly understood. It is thought that NTM is primarily acquired from environmental sites including soil and water as well as water supply systems to homes, hospitals, and clinics and from aerosols generated by flowing water from taps, showers, and fountains. Nonetheless, no direct molecular link has been established between environmental NTM and respiratory CF NTM. Healthcare-associated transmission of NTM among CF patients has been suspected and is of growing concern for CF Centers worldwide. Widespread global transmission of NTM, potentially via person-to-person transmission of fomites and aerosols has been reported. The parent HALT NTM study developed and published a standardized epidemiologic outbreak toolkit for investigation of healthcare-associated NTM outbreaks in CF Care Centers. The investigators are now moving to a prospective investigation, with the long-term goal of real-time early identification and mitigation of potential NTM outbreak investigations coupled with healthcare environmental sampling and home of residence watershed analysis of PwCF identified as belonging to an NTM cluster and receiving care at a single CF Care Center.

Key Dates

Start date
Dec 28, 2022
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: People infected with NTM isolates identified in a cluster
    All people with CF infected with NTM respiratory isolated identified in a cluster based on whole genome sequencing of the core genome will undergo epidemiologic investigation and home of residence watersheds will be mapped.
  • Arm: People infected with NTM isolates not identified in a cluster
    All people with CF infected with NTM respiratory isolated not identified in a cluster based on whole genome sequencing of the core genome will undergo epidemiologic investigation and home of residence watersheds will be mapped.

Primary Outcome Measure

Epidemiologic Investigation [ Time Frame: 3 years ]

Locations (7)

FacilityCityStateZIPSite coordinators
National Jewish HealthDenverColorado80206-
Johns Hopkins Cystic Fibrosis CenterBaltimoreMaryland21287-
Dell Children's AscensionAustinTexas78723-
UT Southwestern Medical CenterDallasTexas75309-
The University of Vermont Medical CenterColchesterVermont05446-
UVA Health University Medical CenterCharlottesvilleVirginia22908-
UW Medical CenterSeattleWashington98195-

Find similar trials in Denver, CO

By research site
National Jewish Health· Denver, COJohns Hopkins Cystic Fibrosis Center· Baltimore, MDDell Children's Ascension· Austin, TXUT Southwestern Medical Center· Dallas, TXThe University of Vermont Medical Center· Colchester, VTUVA Health University Medical Center· Charlottesville, VA

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