RecruitingNCT06155747

Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)


Sponsor

University of North Carolina, Chapel Hill

Enrollment

100 participants

Start Date

Mar 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 1 MonthMax Age: 99 Years

Inclusion Criteria1

  • 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.

Exclusion Criteria1

  • No NTM respiratory culture

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Interventions

OTHEREpidemiologic investigation

Identification 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.


Locations(1)

University of North Carolina- Chapel Hill

Chapel Hill, North Carolina, United States

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