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OpenTrials
Completed

NCT Number: NCT04024423

Healthcare-associated Links in Transmission of Nontuberculous Mycobacteria in 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epidemiologic investigation

Other

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

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

Acronym: HALTNTM

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2019
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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