Status:
NOT_YET_RECRUITING
Antibiotic Stewardship in AECOPD Through CRP-Guided Management
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Food and Health Bureau, Hong Kong
Conditions:
Acute Exacerbation of COPD
Lung Diseases
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
Objectives: To determine whether CRP-guided antibiotic treatment for managing AECOPD in adult patients attending Emergency Departments leads to reduced antibiotic duration, without non-inferior COPD ...
Detailed Description
Introduction Multiple small successes against antimicrobial resistance are urgently needed. The Global Action Plan in 2015 reiterated the importance of tackling antimicrobial abuse and bacterial resi...
Eligibility Criteria
Inclusion
- Being diagnosed with active AECOPD (AECOPD is defined as an event in the natural course of a disease characterized by a change in baseline dyspnoea, cough, and/or sputum that is beyond the normal day-to-day variations with acute onset, which may warrant a change in regular medication in patients with underlying COPD).
- Known COPD in their medical records.
- Age 40 years or older.
- Able to provide informed consent in Cantonese, Mandarin, or English
- Able to complete the questionnaires during the study period (i.e. 6 months after randomisation)
Exclusion
- Patients will be excluded if any ONE of the following are present:
- Pre-treatment with systemic corticosteroids for the present exacerbation.
- Pre-treatment with any antibiotics for the present exacerbation, any concurrent infection or prophylaxis.
- Known clinical stroke in past 6 months
- Patients with high suspicion of active AECOPD mimics:
- Pneumonia
- Congestive heart failure
- Bronchiectasis
- Pulmonary embolism
- Pneumothorax
- Atrial fibrillation / flutter
- Lung comorbidities:
- Cystic fibrosis
- Tuberculosis
- Unresolved lung malignancy
- Progression or new radiographic abnormalities on the chest X-ray.
- Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc., and the use of immunosuppressive drugs for more than 28 days.
- Active inflammatory condition (e.g. flare up of rheumatoid arthritis, gout or polymyalgia rheumatica) or concurrent infection at another site (e.g. UTI, cellulitis) that is likely to produce a systemic response
- Currently pregnant
- NEWS2 score of ≥3
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
1184 Patients enrolled
Trial Details
Trial ID
NCT05286918
Start Date
September 1 2022
End Date
August 31 2026
Last Update
May 23 2022
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, Hong Kong