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NCT Number: NCT06779344

MxA and CRP-Guided Use of Antimicrobial Agents for AECOPD

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MxA and CRP tests

Other

A whole blood sample will be collected on the day of randomization for MxA and CRP testing.

MxA and CRP feedback

Other

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

Other

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.

Primary outcomes

  1. 30-day treatment failure rate

    Time frame: 30 days

    Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 30.

Secondary outcomes

  1. 30-day hospitalization rate

    Time frame: 30 days

    Defined as the proportion of patients who were hospitalized by day 30

  2. 14-day treatment failure rate

    Time frame: 14 days

    Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 14.

  3. The rate of antibiotic prescriptions

    Time frame: 24 hours

    Defined as the proportion of patients who were prescribed antibiotics within 24 hours after randomization

  4. The rate of antiviral prescriptions

    Time frame: 24 hours

    Defined as the proportion of patients who were prescribed antiviral drugs within 24 hours after randomization.

  5. The rate of corticosteroids prescriptions

    Time frame: 24 hours

    Defined as the proportion of patients who were prescribed corticosteroids within 24 hours after randomization.

  6. 30-day antibiotic use rate

    Time frame: 30 days

    Defined as the proportion of patients who received antibiotic treatment by Day 30.

  7. 30-day antiviral use rate

    Time frame: 30 days

    Defined as the proportion of patients who received antiviral treatment by Day 30

  8. 30-day corticosteroids use rate

    Time frame: 30 days

    Defined as the proportion of patients who received corticosteroids treatment by Day 30.

  9. the rate of next exacerbation

    Time frame: 90 days

    Defined as the proportion of patients who experienced another exacerbation of COPD by day 90.

Other outcomes

  1. The CAT symptom score

    Time frame: 14 days, 30 days, 90 days

    The COPD Assessment Test (CAT) symptom score will be measured on Days 1, 14, 30, and 90.

    CAT is used to assess the severity of symptoms in patients with COPD, ranging from 0-40, with higher scores indicating more severe symptoms.

  2. mMRC symptom score

    Time frame: 14 days, 30 days, 90 days

    The modified medical research council (mMRC) will be performed on Day 1, Day 14, Day 30, and Day 90. The mMRC score is used to assess the severity of dyspnea, ranging from 0 (mildest) to 4 (most severe).

Study contacts

Contact information is provided by the study sponsor or research team.

Mengwei Yan, M.D.

CONTACT

[email protected]

Yeming Wang, M.D.

CONTACT

[email protected]

+86 84206264

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Myxovirus Resistance Protein a and C-Reactive Protein-Guided Antimicrobial Treatment in Outpatients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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