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NCT04024423

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

NCT ID: NCT04024423

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2023-07-01

Brief Summary

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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

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Conditions

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Cystic Fibrosis Nontuberculous Mycobacterium Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Epidemiologic investigation

Intervention Type OTHER

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.

Epidemiologic investigation

Intervention Type OTHER

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.

Epidemiologic investigation

Intervention Type OTHER

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.

Epidemiologic investigation

Intervention Type OTHER

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.

Epidemiologic investigation

Intervention Type OTHER

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.

Epidemiologic investigation

Intervention Type OTHER

Identification of overlaps in source(s) of care between participants with NTM isolates in a Cystic Fibrosis Care Center.

Interventions

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Epidemiologic investigation

Identification of overlaps in source(s) of care between participants with NTM isolates in a Cystic Fibrosis Care Center.

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cystic Fibrosis Foundation

OTHER

Sponsor Role collaborator

National Jewish Health

OTHER

Sponsor Role lead

Responsible Party

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Jane Gross

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jane E Gross, MD PhD

Role: STUDY_DIRECTOR

National Jewish Health

Locations

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National Jewish Health

Denver, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED

PMID: 34929010 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

Other Identifiers

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HS-3175

Identifier Type: -

Identifier Source: org_study_id