Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)

NCT06155747 | Recruiting

• 2 other identifiers: 25-0472HS-4062
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Epidemiologic Investigation

  Identification of a shared healthcare-associated source(s) between patients in a healthcare center.

  5 years

• Dust and Water Biofilm Collection

  Identification of healthcare dust and water biofilm NTM isolates that are highly related to the isolates recovered from subjects within a healthcare system.

  5 years

• Home of Residence Watershed Mapping

  The primary endpoint is identification of common watersheds among subjects infected with clustered NTM isolates.

  5 years

Secondary Outcomes (2)

• Geographic Patterns and Genetic Relatedness of Nontuberculous Mycobacteria Across Healthcare Centers

  5 years

• Regional Incidence and Prevalence of Nontuberculous Mycobacteria Identified in Healthcare Dust and Water Biofilm

  5 years

Study Arms (1)

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.

Other: Epidemiologic investigation

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.

People infected with related NTM isolates identified as having membership in a related cluster

Eligibility Criteria

• Age: 1 Month - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female participant of any age who has a history of respiratory NTM or a first positive NTM culture collected as part of routine clinical care from expectorated sputum, induced sputum and/or bronchoalveolar lavage.

You may qualify if:

• 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.

You may not qualify if:

• No NTM respiratory culture

Sponsors & Collaborators

• National Jewish Health: collaborator
• University of North Carolina, Chapel Hill: lead
• University of Texas at Tyler: collaborator

Study Sites (1)

University of North Carolina- Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Publications (4)

• Ankrum AL, Caceres SM, Torsell M, Epperson E, Calado Nogueira de Moura V, Gilick JJ, Strong M, Liu Q, Strand MJ, Wilsey RN, Honda JR, Gross JE, Scaggs-Huang FA. Mycobacterium chelonae outbreak investigation at a quaternary pediatric hospital following the opening of a LEED-certified critical care tower: where does water sustainability intersect with infection control? Infect Control Hosp Epidemiol. 2026 Feb;47(2):161-169. doi: 10.1017/ice.2025.10344. Epub 2025 Nov 24.

  PMID: 41277331 RESULT

• Gross JE, Caceres S, Poch K, Hasan NA, Davidson RM, Epperson LE, Lipner E, Vang C, Honda JR, Strand M, Strong M, Saiman L, Prevots DR, Olivier KN, Nick JA. Healthcare-associated links in transmission of nontuberculous mycobacteria among people with cystic fibrosis (HALT NTM) study: Rationale and study design. PLoS One. 2021 Dec 20;16(12):e0261628. doi: 10.1371/journal.pone.0261628. eCollection 2021.

  PMID: 34929010 RESULT

• Gross JE, Caceres S, Poch K, Hasan NA, Jia F, Epperson LE, Lipner E, Vang C, Honda JR, Strand M, Calado Nogueira de Moura V, Daley CL, Strong M, Davidson RM, Nick JA. Investigating Nontuberculous Mycobacteria Transmission at the Colorado Adult Cystic Fibrosis Program. Am J Respir Crit Care Med. 2022 May 1;205(9):1064-1074. doi: 10.1164/rccm.202108-1911OC.

  PMID: 35085056 RESULT

• Gross JE, Teneback CC, Sweet JG, Caceres SM, Poch KR, Hasan NA, Jia F, Epperson LE, Lipner EM, Vang CK, Honda JR, Strand MJ, Calado Nogueira de Moura V, Daley CL, Strong M, Davidson RM, Nick JA. Molecular Epidemiologic Investigation of Mycobacterium intracellulare Subspecies chimaera Lung Infections at an Adult Cystic Fibrosis Program. Ann Am Thorac Soc. 2023 May;20(5):677-686. doi: 10.1513/AnnalsATS.202209-779OC.

  PMID: 36656594 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Whole genome sequenced nontuberculous mycobacteria isolates will be retained in the Gross Lab at UNC.

MeSH Terms

Conditions

Cross Infection; Mycobacterium Infections

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Jane Gross, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: December 4, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 28, 2036
• Study Completion (Estimated): December 28, 2036
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified IPD and supporting documentation will become available 6 months after publication and will remain available for a period of 3 years thereafter.
• Access Criteria: Access to de-identified IPD will be granted to qualified researchers upon reasonable request. Requests must include a methodologically sound research proposal and will be reviewed for consistency with the original informed consent, ethical considerations, and applicable regulatory requirements. Prior to data release, approval by the University of North Carolina at Chapel Hill (UNC) and execution of a UNC Data Use Agreement (DUA) will be required. Data will be shared only after confirmation that all required institutional approvals and agreements are fully executed. Requests should be directed to the corresponding author.

Locations

US (1)