Prospective, Open-label Study of the Efficacy and Safety of Caspofungin for the Treatment of Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Global response (defined as both clinical and microbiologic success) at the end of intravenous therapy
研究概览
简要总结
The investigators propose to study the efficacy and safety of three-week antifungal therapy with caspofungin in hospitalized patients with proven or probable IPA underlying chronic obstructive pulmonary disease.
详细描述
Recently, there has been increasing appreciation of chronic obstructive pulmonary disease (COPD) as an important risk factor of invasive pulmoanry aspergillosis (IPA). However, clinical data on the morbidity and mortality of IPA underlying COPD as well as the efficacy and safety of antifungal treatment in such subset of patient population is very limited. In clinical pratice, capofungin is often used as primary antifungal therapy for IPA, especially in patients with impaired renal function. Based on this data, the investigators propose to study the efficacy and safety of three-week antifungal therapy with caspofungin in hospitalized patients with proven or probable IPA underlying COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Proven invasive pulmonary aspergillosis
- •Probable invasive pulmonary aspergillosis
- •Hospitalized in respiratory wards
- •Not having received an empirical antifungal therapy for 72h before inclusion
排除标准
- •A history of allergy to echinocandins
- •Severe renal failure, severe hepatic insufficiency
- •Inadequately treated bacterial infection
- •Documented HIV infection
- •Status of pregnancy or lactation
研究组 & 干预措施
caspofungin
干预措施: caspofungin (Drug)
结局指标
主要结局
Global response (defined as both clinical and microbiologic success) at the end of intravenous therapy
时间窗: At end of intravenous treatment(three week)
The primary objective is to investigate the clinical efficacy of 3-week treatment with caspofungin as either primary or salvage antifungal therapy for IPA underlying COPD.
次要结局
- Assessment of Safety of Caspofungin for IPA Underlying COPD(at the time of enrollment, weekly during therapy, and 1 week after the end of therapy.)
- Global response to 2-week caspofungin therapy(2 week)
- Factors such as severity of COPD, exposure to systemic corticosteroids,extended-spectrum antibiotics et al. affecting patients' response to caspofungin therapy(3 week)
- Clinical response at Day 7 of treatment(1 week)
研究者
Feng Ye
Principal Investigator
The First Affiliated Hospital of Guangzhou Medical University