Myxovirus Resistance Protein a and C-Reactive Protein-Guided Antimicrobial Treatment in Outpatients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 458
- 试验地点
- 1
- 主要终点
- 30-day treatment failure rate
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •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.
结局指标
主要结局
30-day treatment failure rate
时间窗: 30 days
Defined as the proportion of patients who had additional medical visits, hospitalization, or death by Day 30.
次要结局
- 30-day hospitalization rate(30 days)
- 14-day treatment failure rate(14 days)
- The rate of antibiotic prescriptions(24 hours)
- the rate of next exacerbation(90 days)
- The rate of antiviral prescriptions(24 hours)
- The rate of corticosteroids prescriptions(24 hours)
- 30-day antibiotic use rate(30 days)
- 30-day antiviral use rate(30 days)
- 30-day corticosteroids use rate(30 days)
研究者
Bin Cao
Professor
Capital Medical University