Healthcare-associated links in transmission of nontuberculous mycobacteria among people with cystic fibrosis (HALT NTM) study: Rationale and study design.
Jane E Gross, Silvia Caceres, Katie Poch...
https://pubmed.ncbi.nlm.nih.gov/34929010Actively Recruiting
Age: 1Month - 99Years
All Genders
ID06155747
Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)
Led by University of North Carolina, Chapel Hill · Updated on 2026-05-26
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
N
National Jewish Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting an observational study to support U.S. healthcare centers in identifying potential outbreaks of nontuberculous mycobacteria (NTM) among patients receiving care. The study applies a standardized investigation approach across various healthcare settings to determine if clusters of NTM infections are linked to healthcare-associated exposure. It focuses on patients with NTM isolates suspected to be part of an outbreak, aiming to compare clinical, epidemiologic, molecular, and infection prevention data to understand transmission patterns. Participants will implement a standardized epidemiologic investigation using the HALT-NTM toolkit, which is a HIPAA-compliant, web-based questionnaire designed to map patient visits and care sources. Respiratory NTM isolates will undergo whole genome sequencing to identify related infections, and environmental samples such as dust and water biofilms may be collected within the healthcare setting to compare with respiratory isolates. Participants may also complete surveys to provide home address history for watershed mapping when clustered infections are identified. Participants will be involved through routine clinical care visits with no additional research visits required. The study collects clinical data, NTM culture results, and uses the HALT-NTM toolkit for epidemiologic investigation. Main outcomes include epidemiologic investigations, environmental sample collection, and watershed mapping over five years. Researchers will monitor geographic and genetic patterns of NTM across healthcare centers to better understand potential healthcare-associated transmission.
CONDITIONS
Brief Title
Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)
Who Can Participate
Age: 1Month - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- No NTM respiratory culture
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
No additional visits beyond routine clinical care
Surveillance
Duration - Up to 5 years
Participants who undergo routine care are observed through collection of clinical data and respiratory NTM isolates as part of routine healthcare to identify highly related clusters of infection.
Data collected during normally scheduled clinic visits
Sample Collection
Duration - Up to 5 years
Dust and water biofilm samples from healthcare environments are collected to identify environmental sources of NTM related to participant infections.
Environmental sampling conducted as part of the outbreak investigation, no participant visits required
Long-term Monitoring
Duration - Up to 5 years
Participants are followed through routine clinical care to monitor geographic patterns and genetic relatedness of NTM infections as well as regional incidence in healthcare environments.
Follow-up occurs during routine healthcare visits
Trial Site Locations
Total: 1 location
1
University of North Carolina- Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
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Research Team
P
Principal Investigator
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Investigating Nontuberculous Mycobacteria Transmission at the Colorado Adult Cystic Fibrosis Program.
Jane E Gross, Silvia Caceres, Katie Poch...
https://pubmed.ncbi.nlm.nih.gov/35085056Molecular Epidemiologic Investigation of Mycobacterium intracellulare Subspecies chimaera Lung Infections at an Adult Cystic Fibrosis Program.
Jane E Gross, Charlotte C Teneback, Julie G Sweet...
https://pubmed.ncbi.nlm.nih.gov/36656594