Non-Tuberculous Mycobacterial PneumoniaNCT04538898
A Retrospective Study Investigating the Factors Related to Non-tuberculous Mycobacterial Pulmonary Disease in Hong Kong
An observational study of Non-Tuberculous Mycobacterial Pneumonia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Tuberculous Mycobacterial Pneumonia
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2020to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Chinese University of Hong
Hong Kong, Please Select
Susanna SS Ng, MBChB, (852) 35053493, ssng@cuhk.edu.hk
About this study
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.
- Conditions
- Non-Tuberculous Mycobacterial Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
diversity of nontuberculous mycobacteria species
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Oct 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Tuberculous Mycobacterial PneumoniaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanna SS Ng, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538898
- Sponsor's protocol ID
- NTM in HK_2019
- Status last verified
- Dec 2020
- First submitted
- 31 Aug 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study Investigating the Factors Related to Non-tuberculous Mycobacterial Pulmonary Disease in Hong Kong
- ClinicalTrials.gov ID
- NCT04538898
- Acronym / sponsor ID
- NTM in HK_2019
- Conditions
- Non-Tuberculous Mycobacterial Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
diversity of nontuberculous mycobacteria species
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Tuberculous Mycobacterial Pneumonia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diversity of nontuberculous mycobacteria species (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.