NCT04538898

Brief Summary

In this retrospective study, we aim to investigate the demographic and clinical features of patients with nontuberculous mycobacteria (NTM) lung disease in our hospital and the trends and diversity of NTM species isolated in the period of 2009-2018.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 31, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

December 10, 2020

Status Verified

December 1, 2020

Enrollment Period

12 months

First QC Date

August 31, 2020

Last Update Submit

December 8, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • diversity of nontuberculous mycobacteria species

    10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Clinical Data Analysis and Reporting System (CDARS) will be queried to identify patients from whom one or more respiratory isolates (namely, sputum, tracheal aspirates, bronchial washing, bronchial aspirates, bronchial trap and bronchoalveolar lavage) of mycobacteria collected in the Prince of Wales Hospital in the period of 2009-2018. Specimen and clinical information is linked through the Clinical Management System (CMS). The clinical history from the CMS will be reviewed to assess the comorbid conditions and baseline demographic information. Laboratory reported use of DNA probes for identification of Mycobacterium avium complex (MAC), M. avium, Mycobacterium intracellulare, Mycobacterium kansasii, and Mycobacterium gordonae, high-performance liquid chromatography and biochemical will be used to identify rapid growers. For trend analysis, no changes in methods for species identification during the study periods will be reported.

You may qualify if:

  • Patients older than 18 years old.
  • patients with one or more respiratory isolates (namely, sputum, tracheal aspirates, bronchial washing, bronchial aspirates, bronchial trap and bronchoalveolar lavage) of mycobacteria collected in the Prince of Wales Hospital in the period of 2009-2018.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese University of Hong

Hong Kong, Please Select, Hong Kong

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 4, 2020

Study Start

October 1, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

December 10, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations