Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-99
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

No NTM respiratory culture

Trial design

Treatments tested in this trial

  • Epidemiologic investigation

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of North Carolina, Chapel Hill

Lead sponsor

National Jewish Health

Collaborator

University of Texas at Tyler

Collaborator