Antibiotic Stewardship in AECOPD Through CRP-Guided Management

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 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.

Conditions

• Acute Exacerbation of COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Tract Disease

Interventions

PROCEDURE

The intervention (CRP-guided) group

The 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).

Sponsors & Collaborators

• Food and Health Bureau, Hong Kong

  collaborator OTHER_GOV

• The University of Hong Kong

  lead OTHER

Principal Investigators

• Ka Chung Abraham WAI · The University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2025-08-31

Completion

2026-08-31

Countries

• Hong Kong

Study Locations