MxA and CRP-Guided Use of Antimicrobial Agents for AECOPD

NCT06779344 · tracked via the Priya Life Science Japan tracker

Sponsor

Capital Medical University

Phase

Not applicable

Started

2025-01-13

Last updated

2025-01-16

Condition(s) studied

Acute Exacerbation Chronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

MxA and CRP testsMxA and CRP feedbackFollow up

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.

Study summary

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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

30-day treatment failure rate — 30 days
Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 30.

Trial sites (1)

Facility	City	Region	Status
China-Japan Friendship hospital	Beijing	Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06779344 on ClinicalTrials.gov ↗ ← All trials in Japan