NCT06779344

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 458 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Acute Exacerbation Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
OTHER	MxA and CRP tests	A whole blood sample will be collected on the day of randomization for MxA and CRP testing.
OTHER	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.
OTHER	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.

Timeline

• Start date: 2025-01-13
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-01-16
• Last updated: 2025-01-16

Locations

1 site across 1 country: China