Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)

Healthcare Associated Infection Clinical Trial

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Official title:

Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06155747
• Other study ID #: HS-4062
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: February 28, 2028

Study information

• Verified date: December 2023
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2028
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Healthcare Associated Infection
• Infections
• Mycobacterium Infections
• Nontuberculous Mycobacterial Pulmonary Infection

Intervention

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.

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

References & 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 — View 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 Fibr — View 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 intra — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidemiologic Investigation	Identification of a shared healthcare-associated source(s) between patients in a healthcare center.	5 years
Primary	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
Primary	Home of Residence Watershed Mapping	The primary endpoint is identification of common watersheds among subjects infected with clustered NTM isolates.	5 years
Secondary	Epidemiologic Investigation	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.	5 years
Secondary	Healthcare Environment Dust and Water Biofilm Collection	Incidence and prevalence of healthcare-associated dust and water biofilm NTM species/subspecies by geographical region.	5 years