University of North Carolina, Chapel Hill
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.
This is a prospective, multicenter, nonrandomized study to investigate potential NTM outbreaks in the six CF Care Centers currently enrolled in the HALT NTM study. The study will investigate potential episodes of healthcare-associated NTM transmission and/or acquisition within participating U.S. Care Centers, coupled with healthcare environmental sampling and home of residence watershed analysis. PART A / Epidemiologic Investigation: The Colorado NTM Outcome Measure Advancement Core National Resource Centers (CO-NRC) provides a national reference laboratory for CF NTM. NTM respiratory isolat…
Inclusion Criteria: * 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 Criteria: * No diagnosis of CF