MxA and CRP-Guided Use of Antimicrobial Agents for AECOPD
Myxovirus Resistance Protein a and C-Reactive Protein-Guided Antimicrobial Treatment in Outpatients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yeming Wang, M.D.
- Phone Number: +86 84206264
- Email: wwyymm_love@163.com
Study Contact Backup
- Name: Mengwei Yan, M.D.
- Email: yanmengwei_happy@126.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100029
- China-Japan Friendship Hospital
-
Contact:
- Bin Cao
- Phone Number: 01084206264
- Email: caobin_ben@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥40 years old；
- Current or former smoker with a minimum smoking history of 10 pack years, clinical diagnosed with mild-to-severe COPD;
- Presenting with an acute exacerbation of COPD
- The severity of AECOPD is mild to moderate.
Exclusion Criteria:
- Required urgent hospitalization
- Received interferon therapy within 30 days before screening
- Had an active systemic inflammatory condition within 30 days prior to screening, such as cerebral infarction, myocardial infarction, or surgery
- Received vaccine in the past 30 days
- Active tuberculosis
- Immunocompromised
- Presenting with current respiratory failure
- Clinical suspicion of pneumonia or pulmonary edema.
- Coexisting bronchiectasis, cystic fibrosis, or asthma
- Had a concurrent infection at another site, such as urinary tract infections or sinusitis;
- Contraindications to antibiotics and/or antivirals
- Known etiology of the present exacerbation
- Pre-treatment with corticosteroids (cumulative dose of methylprednisolone ≥ 80 mg or equivalent dose) for the present exacerbation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MxA and CRP-guided group
Perform MxA and CRP test; Report MxA and CRP results to attending clinicians; Provide MxA and CRP-based guidelines for antimicrobial treatment to the attending clinicians; Conduct follow-up telephone visits on Day 14, Day 30, and Day 90
|
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. |
|
Active Comparator: Usual-care group
Conduct follow-up telephone visits on Day 14, Day 30, and Day 90.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-day treatment failure rate
Time Frame: 30 days
|
Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 30.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-day hospitalization rate
Time Frame: 30 days
|
Defined as the proportion of patients who were hospitalized by day 30
|
30 days
|
|
14-day treatment failure rate
Time Frame: 14 days
|
Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 14.
|
14 days
|
|
The rate of antibiotic prescriptions
Time Frame: 24 hours
|
Defined as the proportion of patients who were prescribed antibiotics within 24 hours after randomization
|
24 hours
|
|
The rate of antiviral prescriptions
Time Frame: 24 hours
|
Defined as the proportion of patients who were prescribed antiviral drugs within 24 hours after randomization.
|
24 hours
|
|
The rate of corticosteroids prescriptions
Time Frame: 24 hours
|
Defined as the proportion of patients who were prescribed corticosteroids within 24 hours after randomization.
|
24 hours
|
|
30-day antibiotic use rate
Time Frame: 30 days
|
Defined as the proportion of patients who received antibiotic treatment by Day 30.
|
30 days
|
|
30-day antiviral use rate
Time Frame: 30 days
|
Defined as the proportion of patients who received antiviral treatment by Day 30
|
30 days
|
|
30-day corticosteroids use rate
Time Frame: 30 days
|
Defined as the proportion of patients who received corticosteroids treatment by Day 30.
|
30 days
|
|
the rate of next exacerbation
Time Frame: 90 days
|
Defined as the proportion of patients who experienced another exacerbation of COPD by day 90.
|
90 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The CAT symptom score
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. |
14 days, 30 days, 90 days
|
|
mMRC symptom score
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).
|
14 days, 30 days, 90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Bin Cao, China-Japan Friendship Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAP-China AECOPD-bundle
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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