Healthcare-associated Links in Transmission of Nontuberculous Mycobacteria in Cystic Fibrosis (HALTNTM)

Healthcare-associated Links in Transmission of Nontuberculous Mycobacteria Among Patients With Cystic Fibrosis

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis; Nontuberculous Mycobacterium Infection
• Intervention / Treatment: Other: Epidemiologic investigation

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with cystic fibrosis and growth of respiratory NTM on one or more occasion that have undergone whole genome sequencing of the NTM core genome at National Jewish Health.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Related M. abscess isolates; 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.	Other: Epidemiologic investigation; Identification of overlaps in source(s) of care between participants with NTM isolates in a Cystic Fibrosis Care Center.
Unrelated M. abscessus isolates; 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.	Other: Epidemiologic investigation; Identification of overlaps in source(s) of care between participants with NTM isolates in a Cystic Fibrosis Care Center.
Related M. avium isolates; 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.	Other: Epidemiologic investigation; Identification of overlaps in source(s) of care between participants with NTM isolates in a Cystic Fibrosis Care Center.
Unrelated M. avium isolates; 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.	Other: Epidemiologic investigation; Identification of overlaps in source(s) of care between participants with NTM isolates in a Cystic Fibrosis Care Center.
Related M. intracellulare isolates; 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.	Other: Epidemiologic investigation; Identification of overlaps in source(s) of care between participants with NTM isolates in a Cystic Fibrosis Care Center.
Unrelated M. intracellulare isolates; 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.	Other: Epidemiologic investigation; Identification of overlaps in source(s) of care between participants with NTM isolates in a Cystic Fibrosis Care Center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Retrospective epidemiologic study	Three years
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	Retrospective epidemiologic study	Three years

Collaborators and Investigators

• Sponsor: National Jewish Health
• Collaborators: Cystic Fibrosis Foundation
• Investigators: Study Director: Jane E Gross, MD PhD, National Jewish Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Pancreatic Diseases; Fibrosis; Mycobacterium Infections; Cystic Fibrosis; Mycobacterium Infections, Nontuberculous
• Other Study ID Numbers: HS-3175 (Other Identifier: BRANY)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No