Healthcare-associated Links in Transmission of Nontuberculous Mycobacteria in Cystic Fibrosis (HALTNTM)

National Jewish Health

Status: Completed

Conditions: Cystic Fibrosis; Nontuberculous Mycobacterium Infection

Treatments: Other: Epidemiologic investigation

Study type: Observational

Funder types: Other

Identifiers

NCT04024423

HS-3175

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 6 patient groups

Related M. abscess isolates

Description:

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.

Treatment:

Other: Epidemiologic investigation

Unrelated M. abscessus isolates

Description:

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.

Treatment:

Other: Epidemiologic investigation

Related M. avium isolates

Description:

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.

Treatment:

Other: Epidemiologic investigation

Unrelated M. avium isolates

Description:

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.

Treatment:

Other: Epidemiologic investigation

Related M. intracellulare isolates

Description:

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.

Treatment:

Other: Epidemiologic investigation

Unrelated M. intracellulare isolates

Description:

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.

Treatment:

Other: Epidemiologic investigation