MxA and CRP-Guided Use of Antimicrobial Agents for AECOPD
NCT ID: NCT06779344
Last Updated: 2025-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
458 participants
INTERVENTIONAL
2025-01-13
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
MxA and CRP tests
A whole blood sample will be collected on the day of randomization for MxA and CRP testing.
MxA and CRP feedback
MxA and CRP results will be reported to the attending physcian within 4 hours, along with antimicrobial treatment guidelines based on these results.
Follow up
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.
Usual-care group
Conduct follow-up telephone visits on Day 14, Day 30, and Day 90.
Follow up
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.
Interventions
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MxA and CRP tests
A whole blood sample will be collected on the day of randomization for MxA and CRP testing.
MxA and CRP feedback
MxA and CRP results will be reported to the attending physcian within 4 hours, along with antimicrobial treatment guidelines based on these results.
Follow up
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Bin Cao
Professor
Principal Investigators
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Bin Cao
Role: STUDY_DIRECTOR
China-Japan Friendship Hospital
Locations
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China-Japan Friendship hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CAP-China AECOPD-bundle
Identifier Type: -
Identifier Source: org_study_id
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