Nontuberculous Mycobacterial Pulmonary InfectionTrANsMItNCT06155747
Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)
An observational study of Nontuberculous Mycobacterial Pulmonary Infection and Outbreak Investigation, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 99 years
- Conditions the study is for
- Nontuberculous Mycobacterial Pulmonary Infection, Outbreak Investigation, Healthcare Associated Infection
- What is being tested?
- Epidemiologic investigation
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 28 Dec 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- No NTM respiratory culture
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina- Chapel Hill
Chapel Hill, North Carolina, 27599
Jane Gross, 919-445-4240, jane_gross@med.unc.edu
Silvia Caceres, 919-445-4240, silvia_caceres@med.unc.edu
About this study
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:
Read more
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
Read the detailed description
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.
- Conditions
- Nontuberculous Mycobacterial Pulmonary Infection, Outbreak Investigation, Healthcare Associated Infection, Mycobacterium Infections
- Being tested
- Epidemiologic investigation
- Keywords
- Epidemiology, Nontuberculous Mycobacterial Pulmonary Infection, Outbreak investigation, Healthcare Associated Infection, Infection transmission, Infection acquisition
- Medical subject headings
- Cross Infection, Mycobacterium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidemiologic investigationOther
Identification of:
- overlaps in source(s) of care between participants with NTM isolates in a healthcare center.
- environmental NTM isolates that are highly related to respiratory isolates.
- common water source exposure among subjects with clustered NTM infections via shared home of residence watershed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Epidemiologic investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiologic Investigation
Identification of a shared healthcare-associated source(s) between patients in a healthcare center.
Measured: 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.
Measured: 5 years
Home of Residence Watershed Mapping
The primary endpoint is identification of common watersheds among subjects infected with clustered NTM isolates.
Measured: 5 years
Secondary outcomes (2)
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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start1 Mar 2023
- Primary completion28 Dec 2036 (estimated)
- Study completion28 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nontuberculous Mycobacterial Pulmonary InfectionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Jewish Health, University of Texas at Tyler
- Responsible party
- Sponsor
- Investigators
- Jane Gross, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155747
- Sponsor's protocol ID
- 25-0472
- Other IDs
- HS-4062
- Acronym
- TrANsMIt
- Status last verified
- May 2026
- First submitted
- 5 May 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 41277331Gross 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.
PubMed 34929010Gross 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.
PubMed 35085056Gross 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.
PubMed 36656594
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)
- ClinicalTrials.gov ID
- NCT06155747
- Acronym / sponsor ID
- TrANsMIt / 25-0472
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Jewish Health, University of Texas at Tyler
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Dec 2036 (estimated)
- Study completion
- 28 Dec 2036 (estimated)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People infected with related NTM isolates identified as having membership in a related cluster | – | Other: Epidemiologic investigationCharacterize 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. |
Who may qualify
- Ages
- 1 month to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- No NTM respiratory culture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidemiologic investigationIdentification 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. | Other | People infected with related NTM isolates identified as having membership in a related cluster |
Primary outcome
Epidemiologic Investigation
Time frame: 5 years
Identification of a shared healthcare-associated source(s) between patients in a healthcare center.
Dust and Water Biofilm Collection
Time frame: 5 years
Identification of healthcare dust and water biofilm NTM isolates that are highly related to the isolates recovered from subjects within a healthcare system.
Home of Residence Watershed Mapping
Time frame: 5 years
The primary endpoint is identification of common watersheds among subjects infected with clustered NTM isolates.
2 secondary outcomes
Geographic Patterns and Genetic Relatedness of Nontuberculous Mycobacteria Across Healthcare Centers
Time frame: 5 years
Regional Incidence and Prevalence of Nontuberculous Mycobacteria Identified in Healthcare Dust and Water Biofilm
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Results publication: PubMed 41277331Ankrum 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.
- Results publication: PubMed 34929010Gross 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.
- Results publication: PubMed 35085056Gross 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.
- Results publication: PubMed 36656594Gross 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jane Gross, MD, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nontuberculous Mycobacterial Pulmonary Infection and Outbreak Investigation, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (919-445-4240, Jane_gross@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiologic Investigation (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06155747, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.