[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575981":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":61,"studyPopulation":55,"armGroups":62,"interventions":76,"overallOfficials":89,"centralContacts":94,"locations":103,"responsibleParty":121,"collaborators":55,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":55,"eligibilityCriteria":130,"healthyVolunteers":126,"sex":131,"minAge":132,"maxAge":55,"enrollmentInfo":133,"targetDuration":55,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":55,"overallStatus":142,"whyStopped":55,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Capital Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"30-day treatment failure rate","Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 30.","30 days",[14,17,21,25,28,31,34,37,40],{"measure":15,"description":16,"timeFrame":12},"30-day hospitalization rate","Defined as the proportion of patients who were hospitalized by day 30",{"measure":18,"description":19,"timeFrame":20},"14-day treatment failure rate","Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 14.","14 days",{"measure":22,"description":23,"timeFrame":24},"The rate of antibiotic prescriptions","Defined as the proportion of patients who were prescribed antibiotics within 24 hours after randomization","24 hours",{"measure":26,"description":27,"timeFrame":24},"The rate of antiviral prescriptions","Defined as the proportion of patients who were prescribed antiviral drugs within 24 hours after randomization.",{"measure":29,"description":30,"timeFrame":24},"The rate of corticosteroids prescriptions","Defined as the proportion of patients who were prescribed corticosteroids within 24 hours after randomization.",{"measure":32,"description":33,"timeFrame":12},"30-day antibiotic use rate","Defined as the proportion of patients who received antibiotic treatment by Day 30.",{"measure":35,"description":36,"timeFrame":12},"30-day antiviral use rate","Defined as the proportion of patients who received antiviral treatment by Day 30",{"measure":38,"description":39,"timeFrame":12},"30-day corticosteroids use rate","Defined as the proportion of patients who received corticosteroids treatment by Day 30.",{"measure":41,"description":42,"timeFrame":43},"the rate of next exacerbation","Defined as the proportion of patients who experienced another exacerbation of COPD by day 90.","90 days",[45,49],{"measure":46,"description":47,"timeFrame":48},"The CAT symptom score","The COPD Assessment Test (CAT) symptom score will be measured on Days 1, 14, 30, and 90.\n\nCAT is used to assess the severity of symptoms in patients with COPD, ranging from 0-40, with higher scores indicating more severe symptoms.","14 days, 30 days, 90 days",{"measure":50,"description":51,"timeFrame":48},"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).",{"allocation":53,"interventionModel":54,"interventionModelDescription":55,"primaryPurpose":56,"observationalModel":55,"timePerspective":55,"maskingInfo":57},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":58,"maskingDescription":55,"whoMasked":59},"SINGLE",[60],"OUTCOMES_ASSESSOR","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.\n\nMyxovirus 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.\n\nThis 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.",[63,71],{"label":64,"type":65,"description":66,"interventionNames":67},"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",[68,69,70],"Other: MxA and CRP tests","Other: MxA and CRP feedback","Other: Follow up",{"label":72,"type":73,"description":74,"interventionNames":75},"Usual-care group","ACTIVE_COMPARATOR","Conduct follow-up telephone visits on Day 14, Day 30, and Day 90.",[70],[77,81,85],{"type":6,"name":78,"description":79,"armGroupLabels":80,"otherNames":55},"MxA and CRP tests","A whole blood sample will be collected on the day of randomization for MxA and CRP testing.",[64],{"type":6,"name":82,"description":83,"armGroupLabels":84,"otherNames":55},"MxA 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.",[64],{"type":6,"name":86,"description":87,"armGroupLabels":88,"otherNames":55},"Follow up","Telephone visit will be conducted on Day 14, Day 30, and Day 90 after randomization.\n\nDay 14 and Day 30 follow-up: antimicrobial usage; additional medical visits, hospitalization, death, symptom scores (CAT score and mMRC score).\n\nDay 90 follow-up: Occurrence of another exacerbation of COPD, symptom scores (CAT score and mMRC score), death.",[64,72],[90],{"name":91,"affiliation":92,"role":93},"Bin Cao","China-Japan Friendship Hospital","STUDY_DIRECTOR",[95,100],{"name":96,"role":97,"phone":98,"phoneExt":55,"email":99},"Yeming Wang, M.D.","CONTACT","+86 84206264","wwyymm_love@163.com",{"name":101,"role":97,"phone":55,"phoneExt":55,"email":102},"Mengwei Yan, M.D.","yanmengwei_happy@126.com",[104],{"facility":105,"status":55,"city":106,"state":107,"zip":108,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":117},"China-Japan Friendship hospital","Beijing","Beijing Municipality","100029","China","CN",{"type":112,"coordinates":113},"Point",[114,115],116.39723,39.9075,{"lat":115,"lon":114},[118],{"name":91,"role":97,"phone":119,"phoneExt":55,"email":120},"01084206264","caobin_ben@163.com",{"type":122,"investigatorFullName":91,"investigatorTitle":123,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"PRINCIPAL_INVESTIGATOR","Professor","100575981","mxa-and-crp-guided-use-of-antimicrobial-agents-for-aecopd-100575981",false,"NCT06779344","MxA and CRP-Guided Use of Antimicrobial Agents for AECOPD","Myxovirus Resistance Protein a and C-Reactive Protein-Guided Antimicrobial Treatment in Outpatients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n* ≥40 years old；\n* Current or former smoker with a minimum smoking history of 10 pack years, clinical diagnosed with mild-to-severe COPD;\n* Presenting with an acute exacerbation of COPD\n* The severity of AECOPD is mild to moderate.\n\nExclusion Criteria:\n\n* Required urgent hospitalization\n* Received interferon therapy within 30 days before screening\n* Had an active systemic inflammatory condition within 30 days prior to screening, such as cerebral infarction, myocardial infarction, or surgery\n* Received vaccine in the past 30 days\n* Active tuberculosis\n* Immunocompromised\n* Presenting with current respiratory failure\n* Clinical suspicion of pneumonia or pulmonary edema.\n* Coexisting bronchiectasis, cystic fibrosis, or asthma\n* Had a concurrent infection at another site, such as urinary tract infections or sinusitis;\n* Contraindications to antibiotics and\u002For antivirals\n* Known etiology of the present exacerbation\n* Pre-treatment with corticosteroids (cumulative dose of methylprednisolone ≥ 80 mg or equivalent dose) for the present exacerbation.","ALL","18 Years",{"count":134,"type":135},458,"ESTIMATED","INTERVENTIONAL",[138],"NA","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).",[141],"Acute Exacerbation Chronic Obstructive Pulmonary Disease","NOT_YET_RECRUITING","2025-01-11",{"date":145,"type":146},"2025-01-16","ACTUAL",{"date":148,"type":135},"2025-01-13",{"date":150,"type":135},"2026-12-31",{"name":5,"class":6},1]