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

Study Overview
=================
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.

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

Conditions
-----------------
Cystic Fibrosis, Nontuberculous Mycobacterium Infection

Intervention / Treatment
-----------------
* Other: Epidemiologic investigation


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Related M. abscess isolates<br>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<br>* Identification of overlaps in source(s) of care between participants with NTM isolates in a Cystic Fibrosis Care Center.<br>|
| Unrelated M. abscessus isolates<br>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<br>* Identification of overlaps in source(s) of care between participants with NTM isolates in a Cystic Fibrosis Care Center.<br>|
| Related M. avium isolates<br>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<br>* Identification of overlaps in source(s) of care between participants with NTM isolates in a Cystic Fibrosis Care Center.<br>|
| Unrelated M. avium isolates<br>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<br>* Identification of overlaps in source(s) of care between participants with NTM isolates in a Cystic Fibrosis Care Center.<br>|
| Related M. intracellulare isolates<br>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<br>* Identification of overlaps in source(s) of care between participants with NTM isolates in a Cystic Fibrosis Care Center.<br>|
| Unrelated M. intracellulare isolates<br>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<br>* Identification of overlaps in source(s) of care between participants with NTM isolates in a Cystic Fibrosis Care Center.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Three years |