MxA and CRP-Guided Use of Antimicrobial Agents for AECOPD (NCT06779344) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
MxA and CRP-Guided Use of Antimicrobial Agents for AECOPD
China458 participantsStarted 2025-01-13
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses MxA and CRP blood markers to decide whether someone with a COPD flare-up actually needs antibiotics — how reliable are these markers for guiding that decision, and could using them instead of standard clinical judgment put me at higher risk of undertreated infection?
2The trial is measuring 30-day treatment failure rates, which means there's a real possibility some participants won't respond well within that window — given my personal COPD severity and history of exacerbations, how concerned should I be about that risk compared to just receiving antibiotics the usual way?
3This study is listed as 'not yet recruiting,' so there's no human safety or outcome data from it yet — should I consider waiting to see early results before thinking about enrolling, or is there a more established treatment path I should pursue first?
4Since this trial involves potentially withholding antibiotics based on biomarker results, what happens if my condition worsens mid-study — is there a clear protocol for switching me to standard antibiotic treatment quickly?
5This trial doesn't have a listed phase, which means it may be a pragmatic or observational study rather than a traditional drug trial — can you help me understand exactly what would be different about my care if I participated compared to how you'd normally manage one of my COPD flare-ups?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.