Cystic Fibrosis, Nontuberculous Mycobacterium Infection
Conditions
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.
Interventions
Identification of overlaps in source(s) of care between participants with NTM isolates in a Cystic Fibrosis Care Center.
Sponsors
Cystic Fibrosis Foundation
National Jewish Health
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Three years | Retrospective epidemiologic study |
| 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 | Three years | Retrospective epidemiologic study |
Countries
United States
Outcome results
None listed