Acute Exacerbation Chronic Obstructive Pulmonary DiseaseNCT06779344
MxA and CRP-Guided Use of Antimicrobial Agents for AECOPD
A study testing MxA and CRP tests, MxA and CRP feedback and Follow up in people with Acute Exacerbation Chronic Obstructive Pulmonary Disease, run by Capital Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Exacerbation Chronic Obstructive Pulmonary Disease
- What is being tested?
- MxA and CRP tests, MxA and CRP feedback and Follow up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mengwei Yan, M.D. contact
China1 site
China-Japan Friendship hospital
Beijing, Beijing Municipality, 100029
Bin Cao, 01084206264, caobin_ben@163.com
About this study
Official title: Myxovirus Resistance Protein a and C-Reactive Protein-Guided Antimicrobial Treatment in Outpatients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease
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).
Read the 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.
- Being tested
- MxA and CRP tests, MxA and CRP feedback, Follow up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MxA and CRP testsOther
A whole blood sample will be collected on the day of randomization for MxA and CRP testing.
MxA and CRP feedbackOther
MxA and CRP results will be reported to the attending physcian within 4 hours, along with antimicrobial treatment guidelines based on these results.
Follow upOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MxA and CRP-guided group | Experimental | 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 Receives: Other: MxA and CRP tests; Other: MxA and CRP feedback; Other: Follow up |
| Usual-care group | Active comparator | Conduct follow-up telephone visits on Day 14, Day 30, and Day 90. Receives: Other: Follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day treatment failure rate
Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 30.
Measured: 30 days
Secondary outcomes (9)
30-day hospitalization rate
Defined as the proportion of patients who were hospitalized by day 30
Measured: 30 days
14-day treatment failure rate
Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 14.
Measured: 14 days
The rate of antibiotic prescriptions
Defined as the proportion of patients who were prescribed antibiotics within 24 hours after randomization
Measured: 24 hours
The rate of antiviral prescriptions
Defined as the proportion of patients who were prescribed antiviral drugs within 24 hours after randomization.
Measured: 24 hours
The rate of corticosteroids prescriptions
Defined as the proportion of patients who were prescribed corticosteroids within 24 hours after randomization.
Measured: 24 hours
30-day antibiotic use rate
Defined as the proportion of patients who received antibiotic treatment by Day 30.
Measured: 30 days
30-day antiviral use rate
Defined as the proportion of patients who received antiviral treatment by Day 30
Measured: 30 days
30-day corticosteroids use rate
Defined as the proportion of patients who received corticosteroids treatment by Day 30.
Measured: 30 days
the rate of next exacerbation
Defined as the proportion of patients who experienced another exacerbation of COPD by day 90.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start13 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 458 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Cao, Capital Medical University
- Investigators
- Bin Cao, Study director, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779344
- Sponsor's protocol ID
- CAP-China AECOPD-bundle
- Status last verified
- Jan 2025
- First submitted
- 23 Dec 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myxovirus Resistance Protein a and C-Reactive Protein-Guided Antimicrobial Treatment in Outpatients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06779344
- Acronym / sponsor ID
- CAP-China AECOPD-bundle
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 458 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 13 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MxA and CRP-guided group | Experimental | Other: MxA and CRP tests, Other: MxA and CRP feedback, Other: Follow upPerform 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 |
| Usual-care group | Active comparator | Other: Follow upConduct follow-up telephone visits on Day 14, Day 30, and Day 90. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MxA and CRP testsA whole blood sample will be collected on the day of randomization for MxA and CRP testing. | Other | MxA and CRP-guided group |
| MxA and CRP feedbackMxA and CRP results will be reported to the attending physcian within 4 hours, along with antimicrobial treatment guidelines based on these results. | Other | MxA and CRP-guided group |
| Follow upTelephone 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. | Other | MxA and CRP-guided group, Usual-care group |
Primary outcome
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.
9 secondary outcomes
30-day hospitalization rate
Time frame: 30 days
14-day treatment failure rate
Time frame: 14 days
The rate of antibiotic prescriptions
Time frame: 24 hours
The rate of antiviral prescriptions
Time frame: 24 hours
The rate of corticosteroids prescriptions
Time frame: 24 hours
30-day antibiotic use rate
Time frame: 30 days
30-day antiviral use rate
Time frame: 30 days
30-day corticosteroids use rate
Time frame: 30 days
the rate of next exacerbation
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: Yes. IPD used in the results publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mengwei Yan, M.D. contact
Bin Cao study director
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MxA and CRP tests, MxA and CRP feedback and Follow up in people with Acute Exacerbation Chronic Obstructive Pulmonary Disease, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeming Wang, M.D. (+86 84206264, wwyymm_love@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day treatment failure rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.