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

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ClinicalTrials.gov Identifier: NCT04024423
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : April 8, 2022
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Jane Gross, National Jewish Health

Study Description
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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.

Condition or disease Intervention/treatment
Cystic Fibrosis Nontuberculous Mycobacterium Infection Other: Epidemiologic investigation

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Healthcare-associated Links in Transmission of Nontuberculous Mycobacteria Among Patients With Cystic Fibrosis
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: Three years ]
    Retrospective epidemiologic study

  2. 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 [ Time Frame: Three years ]
    Retrospective epidemiologic study


Biospecimen Retention:   Samples With DNA
Sputum samples of nontuberculous mycobacteria

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024423


Contacts
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Contact: Jane E Gross, MD PhD 303-270-1876 grossjane@njhealth.org

Locations
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United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Jane E Gross, MD PhD    303-270-1876    grossjane@njhealth.org   
Sponsors and Collaborators
National Jewish Health
Cystic Fibrosis Foundation
Investigators
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Study Director: Jane E Gross, MD PhD National Jewish Health
  Study Documents (Full-Text)

Documents provided by Jane Gross, National Jewish Health:
Study Protocol  [PDF] May 8, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jane Gross, Assistant Professor, National Jewish Health
ClinicalTrials.gov Identifier: NCT04024423    
Other Study ID Numbers: HS-3175
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mycobacterium Infections
Mycobacterium Infections, Nontuberculous
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections