An observational study in Cystic Fibrosis and Nontuberculous Mycobacterium Infection, sponsored by National Jewish Health. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-12-04.
Sponsored by National Jewish Health · Observational
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.
136 studies on the registry are indexed under Mycobacterium Infections; 17 are open to participants now.
This study's enrollment of 100 is below the median of 150 across 54 observational studies indexed under Mycobacterium Infections.
Browse Mycobacterium Infections studies →National Jewish Health is the lead sponsor of 108 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
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
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
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
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
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.
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
Time frame: 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
Time frame: Three years
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — There is no plan to make IPD available to other researchers.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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