A RANDOMIZED CONTROLLED STUDY OF ITRACONAZOLE IN CHRONIC CAVITARY PULMONARY ASPERGILLOSIS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- clinical improvement in cough and hemoptysis
研究概览
简要总结
The purpose of this study is to determine whether there itraconazole is effective in the treatment of chronic cavitary pulmonary aspergillosis
详细描述
The role of itraconazole is still not clear in the treatment of chronic cavitary pulmonary aspergillosis(CCPA). Some studies have shown a beneficial role of itraconazole in reducing hemoptysis. So the present study is aimed at analyzing the role of itraconazole in CCPA.
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
- None
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical symptoms: -presence of chronic pulmonary/systemic symptoms lasting ≥ six weeks.
- •Radiological findings:
- •Evidence of slowly progressive pulmonary lesions over weeks-months including cavities with surrounding inflammation.
- •presence of intracavitary mass with a surrounding crescent of air,and presence of pleural thickening in peripheral lesions.
- •Microbiological/Immunological findings: Positive results in the aspergillus precipitin test, demonstration of aspergillus hyphae in sputum or BAL fluid or cultures of BAL/sputum growing aspergillus species.
- •The diagnosis of CCPA will be made if
- •Patient satisfies at least 1, 2a or 2b and/ or any of the 3rd criteria.
- •FNAC from the cavity wall will be considered in atypical cases
排除标准
- •Invasive aspergillosis
- •Allergic broncho-pulmonary aspergillosis (ABPA)
- •Active tuberculosis or malignancy
- •Pregnant females
研究组 & 干预措施
Itraconazole
Role of itraconazole in CCPA
干预措施: Itraconazole (Drug)
Itraconazole
Role of itraconazole in CCPA
干预措施: treatment in cavitary pulmonary aspergillosis (Drug)
treatment in cavitary pulmonary aspergillosis
Patients in this arm are given conservative management with antitussives, brochial artery embolisation.
干预措施: treatment in cavitary pulmonary aspergillosis (Drug)
结局指标
主要结局
clinical improvement in cough and hemoptysis
时间窗: 6 months
Clinical response- assessed by a decrease in frequency \& intensity of hemoptysis \& cough. Significant clinical response will be considered if there is no recurrence of episodes of moderate-massive hemoptysis. Number of interventions required to control hemoptysis will also be taken as a measure of clinical response
次要结局
- Radiological response of CCPA to itraconazole(6 months)
研究者
Vishwanath gella
vgella
Post Graduate Institute of Medical Education and Research, Chandigarh