Recruiting

Observational Study

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06155747

Conditions

Nontuberculous Mycobacterial Pulmonary Infection

Outbreak Investigation

Healthcare Associated Infection

Mycobacterium Infections

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Interventions

Epidemiologic investigation

Study Details

Brief 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

Study ID

NCT06155747

Start date

Mar 1, 2023

Status verified date

May, 2026

Completion date

Dec 28, 2036

Anticipated

Primary completion date

Dec 28, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • No NTM respiratory culture

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Epidemiologic Investigation [ Time Frame: 5 years ]
  • Dust and Water Biofilm Collection [ Time Frame: 5 years ]
  • Home of Residence Watershed Mapping [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Principal Investigator

919-445-4240Jane_gross@med.unc.edu

Locations

University of North Carolina- Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Jane Gross

919-445-4240jane_gross@med.unc.edu

Silvia Caceres

919-445-4240silvia_caceres@med.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • Epidemiology
  • Nontuberculous Mycobacterial Pulmonary Infection
  • Outbreak investigation
  • Healthcare Associated Infection
  • Infection transmission
  • Infection acquisition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-05-26.