Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)

NCT06155747 | Recruiting

• 1 other identifier: HS-4062
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to facilitate standardized nontuberculous mycobacteria (NTM) outbreak investigations in healthcare centers. The main questions it aims to answer are:

• Are respiratory NTM isolates identified as having membership in a suspected healthcare outbreak highly related based on whole genome sequencing?
• Does epidemiologic investigation support healthcare-associated patient-to-patient NTM transmission?
• Does healthcare environmental sampling support healthcare-associated NTM acquisition? If healthcare-associated NTM outbreaks are suspected, participants identified as having membership in a cluster of highly-related NTM infections will complete a demographic questionnaire.

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

Outcome Measures

Primary Outcomes (3)

• Epidemiologic Investigation

  Identification of a shared healthcare-associated source(s) between patients in a healthcare center.

  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.

  5 years

• Home of Residence Watershed Mapping

  The primary endpoint is identification of common watersheds among subjects infected with clustered NTM isolates.

  5 years

Secondary Outcomes (2)

• Epidemiologic Investigation

  5 years

• Healthcare Environment Dust and Water Biofilm Collection

  5 years

Study Arms (1)

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.

Other: Epidemiologic investigation

Interventions

Epidemiologic investigation OTHER

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.

People infected with related NTM isolates identified as having membership in a related cluster

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 and/or bronchoalveolar lavage.

You may qualify if:

• 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 may not qualify if:

• No NTM respiratory culture

Sponsors & Collaborators

• National Jewish Health: lead

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

Related Publications (3)

• 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

• 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

Biospecimen

Retention: SAMPLES WITH DNA

Whole genome sequenced nontuberculous mycobacteria isolates will be retained in the National Jewish Health biobank.

MeSH Terms

Conditions

Cross Infection; Mycobacterium Infections

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Design

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

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: December 4, 2023
• Study Start: March 1, 2023
• Primary Completion: February 28, 2024
• Study Completion (Estimated): February 28, 2028
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and any additional supporting information will become available 6 months after publication.
• Access Criteria: All IPD will be made available upon request.

Locations

US (1)