NCT04024423

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: National Jewish Health · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis
• Nontuberculous Mycobacterium Infection

Interventions

Type	Name	Description
OTHER	Epidemiologic investigation	Identification of overlaps in source(s) of care between participants with NTM isolates in a Cystic Fibrosis Care Center.

Timeline

• Start date: 2019-07-01
• Primary completion: 2023-05-01
• Completion: 2023-07-01
• First posted: 2019-07-18
• Last updated: 2023-12-04

Locations

1 site across 1 country: United States