Healthcare-associated Links in Transmission of Nontuberculous Mycobacteria in Cystic Fibrosis

Completed

• Conditions: Cystic Fibrosis; Nontuberculous Mycobacterium Infection
• Interventions: Other: Epidemiologic investigation

• Registration Number: NCT04024423
• Lead Sponsor: National Jewish Health

Brief Summary

Sources of NTM infection and modes of transmission among CF patients are poorly understood. Healthcare-associated transmission of NTM among CF patients has been suspected and is of growing concern for CF Centers. There is a need for a systematic evidence-based approach to investigating potential episodes of healthcare-associated transmission. Clusters of highly similar strains of NTM in CF patients cared for at the same CF Center may arise from healthcare sources including patient-to-patient transmission and/or acquisition from water sources within a healthcare setting. The primary objective of the study is to facilitate a standardized process by which CF Centers may perform data abstraction on patients identified with highly similar NTM isolates and determine if clustered NTM strains are related to strains isolated from healthcare setting water biofilm sources. HALT NTM is available to the entire CF Foundation Care Network, under a collaborative agreement, to initiate a standardized, independent, confidential, internal NTM outbreak investigation. Patients that are identified by whole genome sequencing as having highly similar NTM strains and receiving care in the same CF Care Center are eligible. The study's primary endpoint is to identify potential modes and sources of healthcare-associated acquisition of CF NTM, thereby revealing risk factors for NTM acquisition.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-07-16
• Study First Posted: 2019-07-18
• Primary Completion: 2023-05-01
• Study Completion: 2023-07-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Participants with cystic fibrosis and respiratory NTM growth on one or more occasions

Exclusion Criteria

• Participants without cystic fibrosis
• Participants without pulmonary NTM growth

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unrelated M. avium isolates	Epidemiologic investigation	Characterize the source(s) of direct or indirect patient-to-patient transmission of NTM within an individual CF healthcare setting among participants with unrelated isolates.
Related M. abscess isolates	Epidemiologic investigation	Characterize the source(s) of direct or indirect patient-to-patient transmission of NTM within an individual CF healthcare setting among participants with highly related isolates.
Related M. intracellulare isolates	Epidemiologic investigation	Characterize the source(s) of direct or indirect patient-to-patient transmission of NTM within an individual CF healthcare setting among participants with highly related isolates.
Unrelated M. abscessus isolates	Epidemiologic investigation	Characterize the source(s) of direct or indirect patient-to-patient transmission of NTM within an individual CF healthcare setting among participants with unrelated isolates.
Related M. avium isolates	Epidemiologic investigation	Characterize the source(s) of direct or indirect patient-to-patient transmission of NTM within an individual CF healthcare setting among participants with highly related isolates.
Unrelated M. intracellulare isolates	Epidemiologic investigation	Characterize the source(s) of direct or indirect patient-to-patient transmission of NTM within an individual CF healthcare setting among participants with unrelated isolates.

Primary Outcome Measures

Name	Time	Method
Number of cystic fibrosis participants with NTM isolates in related clusters and receiving care in the same Cystic Fibrosis Care Center as assessed by whole genome sequencing	Three years	Retrospective epidemiologic study
Number of cystic fibrosis participants with NTM isolates matching environmental isolates from the participant's Cystic Fibrosis Care Center as assessed by whole genome sequencing	Three years	Retrospective epidemiologic study

Trial Locations

Locations (1)

National Jewish Health; 🇺🇸 Denver, Colorado, United States