The goal of this observational study is to support U.S. healthcare centers in determining if they may have an NTM outbreak among patients receiving care at the healthcare center. The study applies a standardized, reproducible outbreak investigation approach across diverse healthcare settings. This study focuses on patients with NTM isolates suspected to be part of an outbreak, receiving care at a specific U.S. healthcare center.
The main questions it aims to answer are:
Can application of a standardized epidemiologic investigation framework support evaluation of whether clustered NTM infections may be consistent with healthcare-associated exposure? Are respiratory NTM isolates genetically related to environmental NTM isolates identified within healthcare settings or shared home water sources?
Researchers will compare clinical, epidemiologic, molecular, and infection prevention data from suspected NTM isolates to determine whether patterns are consistent with healthcare-associated transmission or acquisition.
Participants (healthcare centers and selected patients) will:
* Implement a standardized epidemiologic investigation using the Healthcare-Associated Links in Transmission of Nontuberculous Mycobacteria (HALT-NTM) toolkit * Submit available respiratory and environmental NTM isolates for molecular comparison, when applicable * Optionally collect dust and water biofilm samples within the healthcare setting * Complete a survey to provide home address history for watershed mapping, when clustered infections are identified
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 and/or bronchoalveolar lavage.
No NTM respiratory culture
Male or female participant of any age who has a history of respiratory NTM or a first positive NTM culture collected as part of routine clinical care from expectorated sputum, induced sputum and/or bronchoalveolar lavage.
Other
Retrospective
Epidemiologic investigation
Other interventionIdentification of: 1. overlaps in source(s) of care between participants with NTM isolates in a healthcare center. 2. environmental NTM isolates that are highly related to respiratory isolates. 3. common water source exposure among subjects with clustered NTM infections via shared home of residence watershed.
Epidemiologic Investigation
Identification of a shared healthcare-associated source(s) between patients in a healthcare center.
Dust and Water Biofilm Collection
Identification of healthcare dust and water biofilm NTM isolates that are highly related to the isolates recovered from subjects within a healthcare system.
Home of Residence Watershed Mapping
The primary endpoint is identification of common watersheds among subjects infected with clustered NTM isolates.
Geographic Patterns and Genetic Relatedness of Nontuberculous Mycobacteria Across Healthcare Centers
Incidence and prevalence of NTM species/subspecies by geographical region. Between Center comparisons of genetic similarity and patterns of potential transmission. Banking of isolates for ex vivo analysis.
Regional Incidence and Prevalence of Nontuberculous Mycobacteria Identified in Healthcare Dust and Water Biofilm
Incidence and prevalence of healthcare-associated dust and water biofilm NTM species/subspecies by geographical region.
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University of North Carolina, Chapel Hill
Lead sponsor
National Jewish Health
Collaborator
University of Texas at Tyler
Collaborator
