China-Japan Friendship hospital
Beijing, Beijing Municipality, 100029, China
NCT Number: NCT06779344
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).
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100029, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 30 days
Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 30.
Time frame: 30 days
Defined as the proportion of patients who were hospitalized by day 30
Time frame: 14 days
Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 14.
Time frame: 24 hours
Defined as the proportion of patients who were prescribed antibiotics within 24 hours after randomization
Time frame: 24 hours
Defined as the proportion of patients who were prescribed antiviral drugs within 24 hours after randomization.
Time frame: 24 hours
Defined as the proportion of patients who were prescribed corticosteroids within 24 hours after randomization.
Time frame: 30 days
Defined as the proportion of patients who received antibiotic treatment by Day 30.
Time frame: 30 days
Defined as the proportion of patients who received antiviral treatment by Day 30
Time frame: 30 days
Defined as the proportion of patients who received corticosteroids treatment by Day 30.
Time frame: 90 days
Defined as the proportion of patients who experienced another exacerbation of COPD by day 90.
Time frame: 14 days, 30 days, 90 days
The COPD Assessment Test (CAT) symptom score will be measured on Days 1, 14, 30, and 90.
CAT is used to assess the severity of symptoms in patients with COPD, ranging from 0-40, with higher scores indicating more severe symptoms.
Time frame: 14 days, 30 days, 90 days
The modified medical research council (mMRC) will be performed on Day 1, Day 14, Day 30, and Day 90. The mMRC score is used to assess the severity of dyspnea, ranging from 0 (mildest) to 4 (most severe).
Contact information is provided by the study sponsor or research team.
Mengwei Yan, M.D.
CONTACT
Yeming Wang, M.D.
CONTACT
Capital Medical University
Other
Myxovirus Resistance Protein a and C-Reactive Protein-Guided Antimicrobial Treatment in Outpatients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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