An observational study in Nontuberculous Mycobacterial Pulmonary Infection, Outbreak Investigation and Healthcare Associated Infection, sponsored by University of North Carolina, Chapel Hill. Recruiting at 1 site in United States. Open to participants aged 1 Month to 99 Years. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by University of North Carolina, Chapel Hill · Observational
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:
This study is a parallel multi-site study of people cared for in a healthcare center who are identified with highly similar respiratory nontuberculous mycobacteria (NTM) isolates. All study activities described herein are optional and conducted at the discretion of each participating site.
This is an outbreak investigation and involves no more than minimal risk, which is commensurate with those inherent in the actual or expected care of a patient with pulmonary NTM. No samples will be collected from the identified participants outside of routine clinical care. As with any research study, there is a potential risk of breach of individual patient confidentiality. Linked to the samples will be clinical data, specifically NTM culture results and designation of NTM disease status, as well as data captured routinely in the course of clinical care. There is no additional testing required for this protocol beyond what is recommended for standard care, and no additional research visits beyond normally scheduled clinic visits.
The Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt) study is designed to provide resources to systematically collect data to perform an outbreak investigation on people in a suspected healthcare-associated NTM outbreak. Respiratory NTM isolates will undergo WGS to identify infections that are highly related and falling into clusters in order to determine if the source of NTM infection may be a healthcare-associated outbreak. The investigators integrated clinical and epidemiological research methods to adapt a CDC standardized, and validated Healthcare-Associated Infection Outbreak Investigation Toolkit to retrospectively collect data for suspected healthcare-associated NTM outbreak investigations. Through consultation with subject matter experts and scientific literature review, the investigators modified the CDC Healthcare-Associated Infection Outbreak Investigation Abstraction Form, designed to be utilized in local investigations of common healthcare-associated infections to develop the Healthcare-associated links in transmission of NTM (HALT NTM) study Outbreak Investigation Abstraction Toolkit. The HALT NTM Toolkit is a Health Insurance Portability and Accountability Act (HIPAA) compliant, web-based, branching logic questionnaire that uses integrated clinical and epidemiological research methods to perform an epidemiologic investigation to identify overlaps in space and time with mapping of visits and source(s) of care among patients with highly similar NTM isolates in a Center. Additionally, the Toolkit assesses detailed Center-specific IP\&C measures utilized the healthcare system. Utilizing the HALT NTM toolkit, the TrANsMit study facilitates a standardized, stepwise process by which healthcare centers perform an internal epidemiologic evaluation of patients identified as part of an NTM cluster. Since clustered NTM isolates could originate from a shared healthcare source, dust and water biofilms from the healthcare environment are collected. NTM are recovered, identified, and sequenced as described to determine if the respiratory NTM strain genotype is similar to those recovered from the healthcare environment. Through a collaborative agreement, TrANsMIt is available to U.S. healthcare centers to conduct a standardized, independent, confidential NTM outbreak investigation.
285 studies on the registry are indexed under Cross Infection; 48 are open to participants now.
This study's planned enrollment of 100 is below the median of 351 across 115 observational studies indexed under Cross Infection.
Browse Cross Infection studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
Epidemiologic Investigation
Identification of a shared healthcare-associated source(s) between patients in a healthcare center.
Time frame: 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.
Time frame: 5 years
Home of Residence Watershed Mapping
The primary endpoint is identification of common watersheds among subjects infected with clustered NTM isolates.
Time frame: 5 years
Geographic Patterns and Genetic Relatedness of Nontuberculous Mycobacteria Across Healthcare Centers
Incidence and prevalence of NTM species/subspecies by geographical region. Between Center comparisons of genetic similarity and patterns of potential transmission. Banking of isolates for ex vivo analysis.
Time frame: 5 years
Regional Incidence and Prevalence of Nontuberculous Mycobacteria Identified in Healthcare Dust and Water Biofilm
Incidence and prevalence of healthcare-associated dust and water biofilm NTM species/subspecies by geographical region.
Time frame: 5 years
Plan to share: Yes — There is a plan to make de-identified IPD and related data dictionaries available. All IPD will be made available upon reasonable request. Requests will be reviewed to ensure alignment with the original informed consent and applicable ethical and regulatory requirements.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
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