- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05112055
Microbiology and Treatment Outcome of Acute Exacerbation of Bronchiectasis in Hong Kong
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
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Charles Wong
- Phone Number: 25956111
- Email: wc679@ha.org.hk
Study Locations
-
-
Other
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Hong Kong, Other, Hong Kong
- Recruiting
- Charles Wong
-
Contact:
- Charles Wong
- Phone Number: 25956111
- Email: wc679@ha.org.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria
- 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.
Exclusion criteria
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microbiology
Time Frame: 1 month
|
Frequency of pseudomonas aeruginosa (PA) and non-PA infection
|
1 month
|
|
Risk factors for PA infection
Time Frame: 1 month
|
Risk factors for PA infection
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Antibiotics use
Time Frame: 1 month
|
Length of antibiotics use (days)
|
1 month
|
|
Length of stay
Time Frame: 1 month
|
Length of hospital stay for AEB (days)
|
1 month
|
|
Recurrent exacerbation
Time Frame: 12 months
|
Frequency of recurrent exacerbation
|
12 months
|
|
Mortality
Time Frame: 12 months
|
Rate of all-cause mortality in 1 year
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Charles Wong, Pamela Youde Nethersole Eastern Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro_AEB_2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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