Clinical trial NCT05112055: Microbiology and Treatment Outcome of Acute Exacerbation of Bronchiectasis in Hong Kong
Official title: Microbiology and Treatment Outcome of Acute Exacerbation of Bronchiectasis in Hong Kong: a Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchiectasis
Lead sponsor: Pamela Youde Nethersole Eastern Hospital
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective observational study of patients who are admitted to the participating hospital with acute exacerbations of bronchiectasis.

Brief 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

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Microbiology
timeFrame: 1 month
measure: Risk factors for PA infection
timeFrame: 1 month
Secondary outcomes:
measure: Antibiotics use
timeFrame: 1 month
measure: Length of stay
timeFrame: 1 month
measure: Recurrent exacerbation
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Charles Wong
state: Other
Study officials:
affiliation: Pamela Youde Nethersole Eastern Hospital
name: Charles Wong
role: PRINCIPAL_INVESTIGATOR
References: