Antibiotic Stewardship in AECOPD Through CRP-Guided Management

Launched by THE UNIVERSITY OF HONG KONG · Mar 9, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to manage acute exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) using a test called CRP (C-reactive protein) to guide antibiotic treatment. In simpler terms, the researchers want to find out if using CRP levels can help doctors decide when to stop antibiotics earlier, without affecting the patients' breathing and overall health compared to standard care. They will include around 1,184 adult patients who are 40 years or older, have a diagnosed history of COPD, and can provide consent in Cantonese, Mandarin, or English. Patients currently taking certain medications or with specific health issues will not be eligible to participate.

If you join this trial, you will receive usual care for AECOPD, but the doctors will also check your CRP levels daily. If your CRP level is high, you may be given antibiotics, but if it drops and you are feeling better, the doctors will consider stopping them sooner. The goal is to see if this approach can reduce the number of days you need antibiotics while still keeping your COPD symptoms under control. Throughout the study, you will answer some questionnaires about your health, and your progress will be monitored. This trial aims to ensure that patients receive the right treatment without unnecessary antibiotics, which is important for your health and the community.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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).
• • 2. Known COPD in their medical records.
• • 3. Age 40 years or older.
• • 4. Able to provide informed consent in Cantonese, Mandarin, or English
• • 5. Able to complete the questionnaires during the study period (i.e. 6 months after randomisation)
• Exclusion Criteria:
• Patients will be excluded if any ONE of the following are present:
• • 1. Pre-treatment with systemic corticosteroids for the present exacerbation.
• • 2. Pre-treatment with any antibiotics for the present exacerbation, any concurrent infection or prophylaxis.
• • 3. Known clinical stroke in past 6 months
• 4. Patients with high suspicion of active AECOPD mimics:
• • 1. Pneumonia
• • 2. Congestive heart failure
• • 3. Bronchiectasis
• • 4. Pulmonary embolism
• • 5. Pneumothorax
• • 6. Atrial fibrillation / flutter
• 5. Lung comorbidities:
• • 1. Cystic fibrosis
• • 2. Tuberculosis
• • 3. Unresolved lung malignancy
• • 6. Progression or new radiographic abnormalities on the chest X-ray.
• • 7. Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc., and the use of immunosuppressive drugs for more than 28 days.
• • 8. 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
• • 9. Currently pregnant
• • 10. NEWS2 score of ≥3