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Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)

NCT06155747 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-05-26

No results posted yet for this study

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

Conditions

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

Interventions

OTHER

Epidemiologic 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.

Sponsors & Collaborators

  • National Jewish Health

    collaborator OTHER

  • University of Texas at Tyler

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Jane Gross, MD, PhD · University of North Carolina, Chapel Hill

Eligibility

Min Age
1 Month
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2036-12-28
Completion
2036-12-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06155747 on ClinicalTrials.gov