Acute Exacerbation Chronic Obstructive Pulmonary Disease
Conditions
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.
Interventions
OTHERMxA and CRP tests
A whole blood sample will be collected on the day of randomization for MxA and CRP testing.
OTHERMxA 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.
OTHERFollow 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.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day treatment failure rate | 30 days | Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 30. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day hospitalization rate | 30 days | Defined as the proportion of patients who were hospitalized by day 30 |
| 14-day treatment failure rate | 14 days | Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 14. |
| The rate of antibiotic prescriptions | 24 hours | Defined as the proportion of patients who were prescribed antibiotics within 24 hours after randomization |
| The rate of antiviral prescriptions | 24 hours | Defined as the proportion of patients who were prescribed antiviral drugs within 24 hours after randomization. |
| The rate of corticosteroids prescriptions | 24 hours | Defined as the proportion of patients who were prescribed corticosteroids within 24 hours after randomization. |
| 30-day corticosteroids use rate | 30 days | Defined as the proportion of patients who received corticosteroids treatment by Day 30. |
| the rate of next exacerbation | 90 days | Defined as the proportion of patients who experienced another exacerbation of COPD by day 90. |
| 30-day antibiotic use rate | 30 days | Defined as the proportion of patients who received antibiotic treatment by Day 30. |
| 30-day antiviral use rate | 30 days | Defined as the proportion of patients who received antiviral treatment by Day 30 |
Other
| Measure | Time frame | Description |
|---|---|---|
| The CAT symptom score | 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. |
| mMRC symptom score | 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). |
Countries
China
Contacts
Primary ContactYeming Wang, M.D.
Backup ContactMengwei Yan, M.D.
Outcome results
None listed