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Tracks how nontuberculous mycobacteria spread among people with cystic fibrosis

Studies how lung germs called nontuberculous mycobacteria may pass between people with cystic fibrosis.

Plain-language title generated from the registry record
Registry title: Prospective Healthcare-Associated Links in Transmission of Nontuberculous Mycobacteria

Key facts

Where
Austin, Baltimore, Charlottesville, Colchester, Dallas, Denver, and Seattle, United StatesSee the 7 sites

Where in United States

  • Dell Children's AscensionAustin, United StatesNo longer taking part
  • Johns Hopkins Cystic Fibrosis CenterBaltimore, United StatesNo longer taking part
  • UVA Health University Medical CenterCharlottesville, United StatesNo longer taking part
  • The University of Vermont Medical CenterColchester, United StatesNo longer taking part
  • UT Southwestern Medical CenterDallas, United StatesNo longer taking part
  • National Jewish HealthDenver, United StatesNo longer taking part
  • UW Medical CenterSeattle, United StatesNo longer taking part

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Trial details

Who runs it
University of North Carolina, Chapel Hill
Trial code
NCT05686837
Record updated
3 November 2026
Original description
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.Read full original descriptionShow less

Prospective Healthcare-Associated Links in Transmission of Nontuberculous Mycobacteria Among People With Cystic Fibrosis

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.

Inclusion: Diagnosis of CF consistent with the 2017 CFF guidelines; Male or female participant of any age who has a history of NTM or a first positive NTM culture collected as part of routine clinical care from expectorated sputum, induced sputum, throat/oropharyngeal swab and/or bronchoalveolar lavage.

Exclusion: No diagnosis of CF.

ClinicalTrials.gov NCT05686837