Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06155747
Status
Recruiting
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Conditions

  • Healthcare Associated Infection
  • Mycobacterium Infections
  • Nontuberculous Mycobacterial Pulmonary Infection
  • Outbreak Investigation

Eligibility Criteria

Sex
ALL
Age
1 Month - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Epidemiologic investigation — OTHER
    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.

Study Details

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

Key Dates

Start date
Mar 1, 2023
Status verified
May 2026
Primary completion
Dec 28, 2036
Completion
Dec 28, 2036

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: People infected with related NTM isolates identified as having membership in a related cluster
    Characterize the source(s) of acquisition and/or direct or indirect patient-to-patient transmission of NTM within a healthcare setting among participants with highly related isolates.

Primary Outcome Measure

Epidemiologic Investigation [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina- Chapel HillChapel HillNorth Carolina27599
Jane Gross
[email protected]
919-445-4240
Silvia Caceres
[email protected]
919-445-4240

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By research site
University of North Carolina- Chapel Hill· Chapel Hill, NC

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