BronchiectasisNCT05112055
Microbiology and Treatment Outcome of Acute Exacerbation of Bronchiectasis in Hong Kong
An observational study of Bronchiectasis, run by Pamela Youde Nethersole Eastern Hospital at 1 site in Hong Kong.
Trial summary
Bronchiectasis is a common disease worldwide with a high burden on healthcare resources. In Hong Kong (HK), local microbiological and clinical data regarding acute exacerbation of bronchiectasis (AEB) is lacking, in particular the frequency of pseudomonas aeruginosa (PA) in AEB is yet to be elucidated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Dec 2021to 1 Dec 2025
- 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: This is a prospective observational study of patients who are admitted to the participating hospital with acute exacerbations of bronchiectasis.
Who may be able to join
- Patients admitted to participating hospital with a clinical diagnosis of acute exacerbation of bronchiectasis (AEB), defined as a change in bronchiectasis treatment associated with deterioration in three or more of the following key symptoms for at least 48 hours: cough; sputum volume and/or consistency; sputum purulence; breathlessness and/or exercise tolerance; fatigue and/or malaise; or haemoptysis.
- Patients with an established diagnosis of bronchiectasis, defined as the presence of cough, shortness of breath, chronic sputum production, recurrent respiratory infection, or a combination thereof with CT thorax scan confirmation of the presence of bronchiectasis indicated by a bronchoarterial ratio of > 1, lack of tapering, airway visibility within 1 cm of the pleural surface, or a combination thereof.
Who cannot join
- Patients unable to provide informed consent
- Age < 18 years
- Pregnancy
- Bronchiectasis due to known cystic fibrosis
- Bronchiectasis is not the main or co-dominant respiratory disease
- Traction bronchiectasis due to interstitial lung disease
- Prior lung transplantation for bronchiectasis
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Charles Wong
Hong Kong, Other
Charles Wong, 25956111, wc679@ha.org.hk
About this study
Official title: Microbiology and Treatment Outcome of Acute Exacerbation of Bronchiectasis in Hong Kong: a Prospective Study
Bronchiectasis is a common disease worldwide with a high burden on healthcare resources. In Hong Kong (HK), local microbiological and clinical data regarding acute exacerbation of bronchiectasis (AEB) is lacking, in particular the frequency of pseudomonas aeruginosa (PA) in AEB is yet to be elucidated. A better understanding of the microbiology of AEB will provide evidence for judicious use of appropriate antibiotics in patients hospitalized for AEB to facilitate treatment and discharge.
This study aims to
- elucidate the microbiology of AEB using both traditional culture and newer molecular multiplex methods,
- identify factors associated with PA infection, and
- describe the management and treatment outcome of AEB in HK
Read the detailed description
Bronchiectasis is a common disease worldwide with a high burden on healthcare resources. In Hong Kong (HK), bronchiectasis ranked 5th highest as a cause of respiratory mortality, was the 6th highest reason for respiratory inpatient bed-days and was the 7th highest cause of respiratory hospitalization in Hong Kong in 2005.
Local microbiological and clinical data regarding acute exacerbation of bronchiectasis (AEB) is lacking, in particular the frequency of pseudomonas aeruginosa (PA) in AEB is yet to be elucidated. Traditional respiratory specimen takes time and lack sensitivity, a newer multiplex molecular method may be beneficial in improving sensitivity and reducing turnover time to detect pathogens involved in AEB. A better understanding of the microbiology of AEB will provide evidence for judicious use of appropriate antibiotics in patients hospitalized for AEB to facilitate treatment and discharge.
This study aims to
- elucidate the microbiology of AEB using both traditional culture and newer molecular multiplex methods,
- identify factors associated with PA infection, and
- describe the management and treatment outcome of AEB in HK
- Conditions
- Bronchiectasis
- Medical subject headings
- Bronchiectasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiology
Frequency of pseudomonas aeruginosa (PA) and non-PA infection
Measured: 1 month
Risk factors for PA infection
Risk factors for PA infection
Measured: 1 month
Secondary outcomes (4)
Antibiotics use
Length of antibiotics use (days)
Measured: 1 month
Length of stay
Length of hospital stay for AEB (days)
Measured: 1 month
Recurrent exacerbation
Frequency of recurrent exacerbation
Measured: 12 months
Mortality
Rate of all-cause mortality in 1 year
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start2 Dec 2021
- Primary completion28 Feb 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamela Youde Nethersole Eastern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong Charles, Pamela Youde Nethersole Eastern Hospital
- Investigators
- Charles Wong, Principal investigator, Pamela Youde Nethersole Eastern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112055
- Sponsor's protocol ID
- Pro_AEB_2021
- Status last verified
- Apr 2024
- First submitted
- 8 Oct 2021
- Last updated
- 3 Apr 2024
- 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 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiology and Treatment Outcome of Acute Exacerbation of Bronchiectasis in Hong Kong: a Prospective Study
- ClinicalTrials.gov ID
- NCT05112055
- Acronym / sponsor ID
- Pro_AEB_2021
- Conditions
- Bronchiectasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pamela Youde Nethersole Eastern HospitalUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 8 Nov 2021 (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.
Bronchiectasis is a common disease worldwide with a high burden on healthcare resources. In Hong Kong (HK), local microbiological and clinical data regarding acute exacerbation of bronchiectasis (AEB) is lacking, in particular the frequency of pseudomonas aeruginosa (PA) in AEB is yet to be elucidated. A better understanding of the microbiology of AEB will provide evidence for judicious use of appropriate antibiotics in patients hospitalized for AEB to facilitate treatment and discharge.
This study aims to
- elucidate the microbiology of AEB using both traditional culture and newer molecular multiplex methods,
- identify factors associated with PA infection, and
- describe the management and treatment outcome of AEB in HK
Detailed description
Bronchiectasis is a common disease worldwide with a high burden on healthcare resources. In Hong Kong (HK), bronchiectasis ranked 5th highest as a cause of respiratory mortality, was the 6th highest reason for respiratory inpatient bed-days and was the 7th highest cause of respiratory hospitalization in Hong Kong in 2005.
Local microbiological and clinical data regarding acute exacerbation of bronchiectasis (AEB) is lacking, in particular the frequency of pseudomonas aeruginosa (PA) in AEB is yet to be elucidated. Traditional respiratory specimen takes time and lack sensitivity, a newer multiplex molecular method may be beneficial in improving sensitivity and reducing turnover time to detect pathogens involved in AEB. A better understanding of the microbiology of AEB will provide evidence for judicious use of appropriate antibiotics in patients hospitalized for AEB to facilitate treatment and discharge.
This study aims to
- elucidate the microbiology of AEB using both traditional culture and newer molecular multiplex methods,
- identify factors associated with PA infection, and
- describe the management and treatment outcome of AEB in HK
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective observational study of patients who are admitted to the participating hospital with acute exacerbations of bronchiectasis.
Key inclusion criteria (2 listed)
- Patients admitted to participating hospital with a clinical diagnosis of acute exacerbation of bronchiectasis (AEB), defined as a change in bronchiectasis treatment associated with deterioration in three or more of the following key symptoms for at least 48 hours: cough; sputum volume and/or consistency; sputum purulence; breathlessness and/or exercise tolerance; fatigue and/or malaise; or haemoptysis.
- Patients with an established diagnosis of bronchiectasis, defined as the presence of cough, shortness of breath, chronic sputum production, recurrent respiratory infection, or a combination thereof with CT thorax scan confirmation of the presence of bronchiectasis indicated by a bronchoarterial ratio of > 1, lack of tapering, airway visibility within 1 cm of the pleural surface, or a combination thereof.
Key exclusion criteria (7 listed)
- Patients unable to provide informed consent
- Age < 18 years
- Pregnancy
- Bronchiectasis due to known cystic fibrosis
- Bronchiectasis is not the main or co-dominant respiratory disease
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
Microbiology
Time frame: 1 month
Frequency of pseudomonas aeruginosa (PA) and non-PA infection
Risk factors for PA infection
Time frame: 1 month
Risk factors for PA infection
4 secondary outcomes
Antibiotics use
Time frame: 1 month
Length of stay
Time frame: 1 month
Recurrent exacerbation
Time frame: 12 months
Mortality
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
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Bronchiectasis
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.
Charles Wong principal investigator
Pamela Youde Nethersole Eastern Hospital
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 Bronchiectasis, run by Pamela Youde Nethersole Eastern Hospital 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 7 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 3 Apr 2024. 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?
Contact Charles Wong (25956111, wc679@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiology (time frame: 1 month). The study lists 2 primary outcomes in all. 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 3 Apr 2024.