MxA and CRP-Guided Use of Antimicrobial Agents for AECOPD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Medical University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
MxA and CRP tests
Other interventionA whole blood sample will be collected on the day of randomization for MxA and CRP testing.
MxA and CRP feedback
Other interventionMxA 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 interventionTelephone 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.
Treatment groups
458 Participants
are divided into 2 treatment groupsGroup A: MxA and CRP-guided groupExperimental treatment 3 interventions
Group B: Usual-care groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
30-day treatment failure rate
Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 30.
Time frame
30 daysSecondary outcomes
1
30-day hospitalization rate
Defined as the proportion of patients who were hospitalized by day 30
Time frame
30 days2
14-day treatment failure rate
Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 14.
Time frame
14 days3
The rate of antibiotic prescriptions
Defined as the proportion of patients who were prescribed antibiotics within 24 hours after randomization
Time frame
24 hours4
The rate of antiviral prescriptions
Defined as the proportion of patients who were prescribed antiviral drugs within 24 hours after randomization.
Time frame
24 hoursOther outcomes
1
The CAT symptom score
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.
Time frame
14 days, 30 days, 90 days2
mMRC symptom score
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).
Time frame
14 days, 30 days, 90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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