This randomized controlled trial will investigate the clinical impact of Myxovirus Resistance A (MxA) and C-Reactive Protein (CRP)-guided antimicrobial treatment compared to usual care in outpatients with acute exacerbations of chronic obstructive pulmonary disease (AECOPD).
Respiratory viral infections are a leading cause of acute exacerbations of chronic obstructive pulmonary disease (AECOPD). However, there is currently a lack of rapid diagnostic methods to differentiate the cause of AECOPD, resulting in insufficient attention to viral-induced exacerbations, with antibiotic treatment remaining the primary treatment. Myxovirus resistance protein A (MxA) has been identified as a potential biomarker to distinguish respiratory viral infections, while C-reactive protein (CRP) has been confirmed as a useful guide for antibiotic therapy in AECOPD. This randomized controlled trial aims to investigate the clinical value of MxA and CRP-guided antimicrobial treatment in outpatients with AECOPD, with the goal of reducing antibiotic overuse and improving patient outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
458
A whole blood sample will be collected on the day of randomization for MxA and CRP testing.
MxA and CRP results will be reported to the attending physcian within 4 hours, along with antimicrobial treatment guidelines based on these results.
Telephone visit will be conducted on Day 14, Day 30, and Day 90 after randomization. Day 14 and Day 30 follow-up: antimicrobial usage; additional medical visits, hospitalization, death, symptom scores (CAT score and mMRC score). Day 90 follow-up: Occurrence of another exacerbation of COPD, symptom scores (CAT score and mMRC score), death.
China-Japan Friendship hospital
Beijing, Beijing Municipality, China
30-day treatment failure rate
Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 30.
Time frame: 30 days
30-day hospitalization rate
Defined as the proportion of patients who were hospitalized by day 30
Time frame: 30 days
14-day treatment failure rate
Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 14.
Time frame: 14 days
The rate of antibiotic prescriptions
Defined as the proportion of patients who were prescribed antibiotics within 24 hours after randomization
Time frame: 24 hours
The rate of antiviral prescriptions
Defined as the proportion of patients who were prescribed antiviral drugs within 24 hours after randomization.
Time frame: 24 hours
The rate of corticosteroids prescriptions
Defined as the proportion of patients who were prescribed corticosteroids within 24 hours after randomization.
Time frame: 24 hours
30-day antibiotic use rate
Defined as the proportion of patients who received antibiotic treatment by Day 30.
Time frame: 30 days
30-day antiviral use rate
Defined as the proportion of patients who received antiviral treatment by Day 30
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Time frame: 30 days
30-day corticosteroids use rate
Defined as the proportion of patients who received corticosteroids treatment by Day 30.
Time frame: 30 days
the rate of next exacerbation
Defined as the proportion of patients who experienced another exacerbation of COPD by day 90.
Time frame: 90 days