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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4 years study duration

Study Start

First participant enrolled

July 1, 2019

Completed

14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2019

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed

Last Updated

December 4, 2023

Status Verified

December 1, 2023

Enrollment Period

3.8 years

First QC Date

July 15, 2019

Last Update Submit

December 1, 2023

Conditions

Cystic Fibrosis Nontuberculous Mycobacterium Infection

Outcome Measures

Primary Outcomes (2)

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

Study Arms (6)

Related M. abscess isolates

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.