Clinical trial NCT06155747: Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)
Official title: Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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. The Advanced Diagnostic Laboratories (ADx) biorepository collects non-standardized, voluntarily submitted respiratory isolates from healthcare centers throughout the U.S. for the purpose of culture, molecular identification, and WGS. 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.

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

Primary outcomes:
measure: Epidemiologic Investigation
timeFrame: 5 years
measure: Dust and Water Biofilm Collection
timeFrame: 5 years
measure: Home of Residence Watershed Mapping
timeFrame: 5 years
Secondary outcomes:
measure: Epidemiologic Investigation
timeFrame: 5 years
measure: Healthcare Environment Dust and Water Biofilm Collection
timeFrame: 5 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.