Prospective Healthcare-Associated Links in Transmission of Nontuberculous Mycobacteria

NCT05686837 | Enrolling By Invitation

• 2 other identifiers: 24-2792HS-3175
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 7

Brief Summary

Pulmonary NTM infection is recognized as one of the most challenging infections to treat among people with cystic fibrosis (PwCF), notable for prolonged treatment courses and often poor response to therapy. Positive cultures for NTM occur in about 20% of children and adults with cystic fibrosis (CF). However, the source of NTM infection, modes of transmission, and exposure risks are poorly understood. It is thought that NTM is primarily acquired from environmental sites including soil and water as well as water supply systems to homes, hospitals, and clinics and from aerosols generated by flowing water from taps, showers, and fountains. Nonetheless, no direct molecular link has been established between environmental NTM and respiratory CF NTM. Healthcare-associated transmission of NTM among CF patients has been suspected and is of growing concern for CF Centers worldwide. Widespread global transmission of NTM, potentially via person-to-person transmission of fomites and aerosols has been reported. The parent HALT NTM study developed and published a standardized epidemiologic outbreak toolkit for investigation of healthcare-associated NTM outbreaks in CF Care Centers. The investigators are now moving to a prospective investigation, with the long-term goal of real-time early identification and mitigation of potential NTM outbreak investigations coupled with healthcare environmental sampling and home of residence watershed analysis of PwCF identified as belonging to an NTM cluster and receiving care at a single CF Care Center.

Conditions

Cystic Fibrosis; Nontuberculous Mycobacterial Pulmonary Infection

Keywords

epidemiology; outbreak investigation; transmission; acquisition; nontuberculous mycobacteria

Outcome Measures

Primary Outcomes (3)

• Epidemiologic Investigation

  Identification of a shared healthcare-associated source(s) between patients in a CF Care Center.

  3 years

• Dust and Water Biofilm Collection

  Identification of healthcare dust and water biofilm NTM isolates that are highly related to the isolates recovered from PwCF.

  3 years

• Home of Residence Watershed Mapping

  The primary endpoint is identification of common watersheds among pwCF infected with clustered NTM isolate.

  3 years

Secondary Outcomes (2)

• Epidemiologic Investigation

  3 years

• Dust and Water Biofilm Collection

  3 years

Study Arms (2)

People infected with NTM isolates identified in a cluster

All people with CF infected with NTM respiratory isolated identified in a cluster based on whole genome sequencing of the core genome will undergo epidemiologic investigation and home of residence watersheds will be mapped.

People infected with NTM isolates not identified in a cluster

All people with CF infected with NTM respiratory isolated not identified in a cluster based on whole genome sequencing of the core genome will undergo epidemiologic investigation and home of residence watersheds will be mapped.

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, throat/oropharyngeal swab and/or bronchoalveolar lavage.

You may qualify if:

• Diagnosis of CF consistent with the 2017 CFF guidelines.
• 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, throat/oropharyngeal swab and/or bronchoalveolar lavage.

You may not qualify if:

• No diagnosis of CF

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Cystic Fibrosis Foundation: collaborator
• National Jewish Health: collaborator
• University of Texas at Tyler: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (7)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Johns Hopkins Cystic Fibrosis Center

Baltimore, Maryland, 21287, United States

Location

Dell Children's Ascension

Austin, Texas, 78723, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75309, United States

Location

The University of Vermont Medical Center

Colchester, Vermont, 05446, United States

Location

UVA Health University Medical Center

Charlottesville, Virginia, 22908, United States

Location

UW Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (6)

• Gross JE, Fullmer J, McClelland G, Caceres SM, Poch KR, Hasan NA, Jia F, Epperson LE, Lipner EM, Vang CK, Honda JR, Strand MJ, de Moura VCN, Daley CL, Strong M, Nick JA. Genomic and epidemiologic investigation of Mycobacterium abscessus isolates in a cystic fibrosis center to determine potential routes of transmission. J Cyst Fibros. 2025 Nov;24(6):1114-1123. doi: 10.1016/j.jcf.2025.07.003. Epub 2025 Aug 8.

  PMID: 40783340 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

• Gross JE, Caceres S, Poch K, Epperson LE, Hasan NA, Jia F, Calado Nogueira de Moura V, Strand M, Lipner EM, Honda JR, Strong M, Davidson RM, Daley CL, Nick JA. Prospective healthcare-associated links in transmission of nontuberculous mycobacteria among people with cystic fibrosis (pHALT NTM) study: Rationale and study design. PLoS One. 2023 Dec 20;18(12):e0291910. doi: 10.1371/journal.pone.0291910. eCollection 2023.

  PMID: 38117792 RESULT

• Gross JE, Finklea JD, Caceres SM, Poch KR, Hasan NA, Jia F, Epperson LE, Lipner EM, Vang CK, Honda JR, Strand MJ, Nogueira de Moura VC, Daley CL, Strong M, Nick JA. Genomic epidemiology of Mycobacterium abscessus at an adult cystic fibrosis programme reveals low potential for healthcare-associated transmission. ERJ Open Res. 2024 Jul 8;10(4):00165-2024. doi: 10.1183/23120541.00165-2024. eCollection 2024 Jul.

  PMID: 38978544 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nontuberculous mycobacterial isolates from respiratory samples from people with CF will be collected.

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Jane E. Gross, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 17, 2023
• Study Start: December 28, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Will become available 9 months after publication and remain available for a total of 5 years.
• Access Criteria: All IPD will be made available upon request. Deidentified individual data that supports the results will be shared beginning 9 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Locations

US (7)