Clinical trial NCT06779344: MxA and CRP-Guided Use of Antimicrobial Agents for AECOPD
Official title: Myxovirus Resistance Protein a and C-Reactive Protein-Guided Antimicrobial Treatment in Outpatients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Exacerbation Chronic Obstructive Pulmonary Disease
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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 outcomes:
measure: 30-day treatment failure rate
timeFrame: 30 days
Secondary outcomes:
measure: 30-day hospitalization rate
timeFrame: 30 days
measure: 14-day treatment failure rate
timeFrame: 14 days
measure: The rate of antibiotic prescriptions
timeFrame: 24 hours
measure: The rate of antiviral prescriptions
timeFrame: 24 hours
measure: The rate of corticosteroids prescriptions
timeFrame: 24 hours
measure: 30-day antibiotic use rate
timeFrame: 30 days
measure: 30-day antiviral use rate
timeFrame: 30 days
measure: 30-day corticosteroids use rate
timeFrame: 30 days
measure: the rate of next exacerbation
timeFrame: 90 days
Other outcomes:
measure: The CAT symptom score
timeFrame: 14 days, 30 days, 90 days
measure: mMRC symptom score
timeFrame: 14 days, 30 days, 90 days
Locations:
city: Beijing
country: China
facility: China-Japan Friendship hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Bin Cao
role: STUDY_DIRECTOR
References: