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 health status with usual care.
Hypothesis to be tested:
(i) The antibiotic duration in AECOPD patients will be significantly lower for CRP-guided antibiotic discontinuation than usual care; and (ii) COPD health status as measured by the Clinical COPD Questionnaire has no statistically significant difference between two groups.
Design and subjects:
Multi-center, single-blind, open-label, randomized, combined superiority (antibiotic duration) and non-inferiority (COPD health status) trial in 1,184 adult AECOPD patients presented to A\&E.
Instruments:
Clinical COPD Questionnaire and EuroQol-5D
Interventions:
Both intervention and control groups follow usual care with GOLD strategy. The intervention group will be recommended to test for serum CRP daily. Antibiotic prescription is considered when CRP \>5mg/dL. Once CRP has declined to \<5mg/dL and the patient was afebrile for past 48 hours, antibiotic discontinuation will be considered.
Communication with Receiving Ward Staffs:
Participants in the study may transfer to another departments after treatment/ care in A\&E. The following communication would be conducted:
* A handover note that informs the receiving ward staffs about patients' enrolment to the trial, group assignment, and previous treatments given in A\&E. The note would also suggest the investigations for the receiving ward staffs. * Telephone handover about intervention group and investigations of the study, and treatments given in A\&E to ward.
Main outcome measures:
The antibiotic duration (total number of antibiotic days) within 28 days and recovery in terms of COPD health status (Clinical COPD Questionnaire total scores) within 14 days from randomisation.
Data analysis:
Intention-to-treat and cost-effectiveness analyses will be performed. The outcome assessors and data analysts will be blinded to group allocation.
Expected results:
The intervention group will exhibit reduction in antibiotic duration at 4-weeks, without negatively impacting on COPD health status, compared with the control group.
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
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
Pneumonia
Parallel
The intervention (CRP-guided) group
Procedure/SurgeryThe attending doctor will use the CRP level to inform their decision to continue antibiotics around 3 hours from blood taking. These doctors will be provided pre-study training on CRP interpretation. Every day from randomization, serum CRP testing will be encouraged to take. Once CRP has declined to \<5mg/dL and the patient has remained afebrile for past 48 hours, antibiotic treatment will be reviewed for discontinuation. Otherwise, antibiotic treatment will be continued. A switch on the administration route, or a change of antibiotics due to adverse effect, allergy, or suggestion from culture result, is permitted according to in-patient physician's decisions. CRP will continue to be monitored daily upon discharge from that hospital (up to 28 days).
Antibiotic duration
Mean antibiotic duration (in days) within 28-days for AECOPD after randomization, measured at the end of each week, using audio/video call until 28 days post randomization. Medication record is also reviewed at 4-weeks post randomization to capture prescription of antibiotics related or unrelated to AECOPD.
COPD health status by Clinical COPD Questionnaire (CCQ) total scores
The CCQ is a validated and reliable 10-item, self-administered questionnaire. The CCQ consists of three subdomains: symptoms, functional state and mental state. Items are scored on a Likert scale (range 0-60). The final score is the sum of all items divided by 10; separate scores for all three domains can be calculated. Higher scores indicate a worse health status.
Prevalence of potentially pathogenic bacteria cultured from sputum at 4 weeks and the proportion of bacteria that are resistant
Prevalence of commensal organisms cultured from sputum at 4 weeks and the proportion of bacteria that are resistant
Adverse effects potentially attributable to antibiotics prescribed for the exacerbation
Measured by European Quality of Life-5 Dimensions 5-Level questionnaire(EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
All-cause antibiotic consumption
Click on the lead sponsor to view all of their trials.
The University of Hong Kong
Lead sponsor
Food and Health Bureau, Hong Kong
Collaborator
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