MxA and CRP-Guided Use of Antimicrobial Agents for AECOPD

Capital Medical University

Status: Not yet enrolling

Conditions: Acute Exacerbation Chronic Obstructive Pulmonary Disease

Treatments: Other: MxA and CRP tests; Other: Follow up; Other: MxA and CRP feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT06779344

CAP-China AECOPD-bundle

Details and patient eligibility

About

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).

Full 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.

Enrollment: 458 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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458 participants in 2 patient groups

MxA and CRP-guided group

Experimental group

Description:

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

Treatment:

Other: MxA and CRP feedback

Other: Follow up

Other: MxA and CRP tests

Usual-care group

Active Comparator group

Description:

Conduct follow-up telephone visits on Day 14, Day 30, and Day 90.

Treatment:

Other: Follow up