NCT05112055

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. 1.elucidate the microbiology of AEB using both traditional culture and newer molecular multiplex methods,
  2. 2.identify factors associated with PA infection, and
  3. 3.describe the management and treatment outcome of AEB in HK

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

December 2, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

3.2 years

First QC Date

October 8, 2021

Last Update Submit

April 2, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Microbiology

    Frequency of pseudomonas aeruginosa (PA) and non-PA infection

    1 month

  • Risk factors for PA infection

    Risk factors for PA infection

    1 month

Secondary Outcomes (4)

  • Antibiotics use

    1 month

  • Length of stay

    1 month

  • Recurrent exacerbation

    12 months

  • Mortality

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a prospective observational study of patients who are admitted to the participating hospital with acute exacerbations of bronchiectasis.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles Wong

Hong Kong, Other, Hong Kong

RECRUITING

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Officials

  • Charles Wong

    Pamela Youde Nethersole Eastern Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Wong

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Specialist

Study Record Dates

First Submitted

October 8, 2021

First Posted

November 8, 2021

Study Start

December 2, 2021

Primary Completion

February 28, 2025

Study Completion

December 1, 2025

Last Updated

April 3, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations