C: Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)

Sponsor

National Jewish Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT06155747

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nontuberculous Mycobacterial Pulmonary Infection Outbreak Investigation Healthcare Associated Infection Mycobacterium Infections	Other: Epidemiologic investigation

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 NTM isolates. The Advanced Diagnositc 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 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 HALT NTM Outbreak Investigation Abstraction Toolkit. The HALT NTM Toolkit is a 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

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Feb 28, 2028

Arms and Interventions

Arm	Intervention/Treatment
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 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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

Epidemiologic Investigation [5 years]
Identification of a shared healthcare-associated source(s) between patients in a healthcare center.
Dust and Water Biofilm Collection [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 [5 years]
The primary endpoint is identification of common watersheds among subjects infected with clustered NTM isolates.

Secondary Outcome Measures

Epidemiologic Investigation [5 years]
Incidence and prevalence of CF NTM species/subspecies by geographical region. Between Center comparisons of genetic similarity and patterns of potential transmission. Banking of isolates for ex vivo analysis.
Healthcare Environment Dust and Water Biofilm Collection [5 years]
Incidence and prevalence of healthcare-associated dust and water biofilm NTM species/subspecies by geographical region.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.