Microbiology and Treatment Outcome of Acute Exacerbation of Bronchiectasis in Hong Kong

Bronchiectasis Clinical Trial

Official title:

Microbiology and Treatment Outcome of Acute Exacerbation of Bronchiectasis in Hong Kong: a Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05112055
• Other study ID #: Pro_AEB_2021
• Status: Recruiting
• Start date: December 2, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: Pamela Youde Nethersole Eastern Hospital
• Contact: Charles Wong
• Phone: 25956111
• Email: wc679[@]ha.org.hk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

1. elucidate the microbiology of AEB using both traditional culture and newer molecular multiplex methods,

2. identify factors associated with PA infection, and

3. describe the management and treatment outcome of AEB in HK

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

1. elucidate the microbiology of AEB using both traditional culture and newer molecular multiplex methods,

2. identify factors associated with PA infection, and

3. describe the management and treatment outcome of AEB in HK

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. 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.

2. 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

1. Patients unable to provide informed consent

2. Age < 18 years

3. Pregnancy

4. Bronchiectasis due to known cystic fibrosis

5. Bronchiectasis is not the main or co-dominant respiratory disease

6. Traction bronchiectasis due to interstitial lung disease

7. Prior lung transplantation for bronchiectasis

Related Conditions & MeSH terms

• Bronchiectasis

Locations

Country	Name	City	State
Hong Kong	Charles Wong	Hong Kong	Other

Sponsors (1)

Lead Sponsor	Collaborator
Pamela Youde Nethersole Eastern Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiology	Frequency of pseudomonas aeruginosa (PA) and non-PA infection	1 month
Primary	Risk factors for PA infection	Risk factors for PA infection	1 month
Secondary	Antibiotics use	Length of antibiotics use (days)	1 month
Secondary	Length of stay	Length of hospital stay for AEB (days)	1 month
Secondary	Recurrent exacerbation	Frequency of recurrent exacerbation	12 months
Secondary	Mortality	Rate of all-cause mortality in 1 year	12 months