NCT06155747 Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)
| NCT ID | NCT06155747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Nontuberculous Mycobacterial Pulmonary Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2036-12-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-03-01 with a primary completion date of 2036-12-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Jane Gross, MD, PhD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06155747 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 99 Years, studying Nontuberculous Mycobacterial Pulmonary Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06155747 currently recruiting?
Yes, NCT06155747 is actively recruiting participants. Contact the research team at Jane_gross@med.unc.edu for enrollment information.
Where is the NCT06155747 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06155747 clinical trial?
NCT06155747 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Jane Gross, MD, PhD at University of North Carolina, Chapel Hill. The trial plans to enroll 100 participants.