Multicenter observational study on epidemiology, treatment and outcome of Mucormycosis in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 17
- 主要终点
- 1.Overall survival at 45 and 90 days
研究概览
简要总结
Study Summary
| Title |
Multicenter observational study on epidemiology, treatment and outcome of Mucormycosis in India
|Short Title
Description of epidemiology, treatment practice and outcome of mucomycosis in India
|Protocol Number
FISF 001.3
|Phase
IV
|Methodology
Observational study
|Study Duration
1 years
|Study Center(s)
Multi-center.
|Objectives
Primary:
- To describe the epidemiology, diagnosis, treatment practices and outcome of mucormycosis in India
Secondary:
- Sites involved in mucormycosis
- Underlying disease and risk factors for mucormycosis
- Spectrum of agents causing mucormycosis
– mode of diagnosis of mucormycosis
|Number of Subjects
At least 300
|Diagnosis and Main Inclusion Criteria
Proven and probable cases of mucormycosis
|Study Product, Dose, Route, Regimen
No study product will be used as it is only observational study
|Duration of administration
not applicable
|Reference therapy
Not applicable
|Statistical Methodology
Descriptive and quantitative statistics
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Any age group of patients with confirmed & probable diagnosis of Mucormycosis will be enrolled for this study.
排除标准
- •Any subject without a confirmed diagnosis of mucormycosis.
结局指标
主要结局
1.Overall survival at 45 and 90 days
时间窗: 45 and 90 days
2.Cure: defined as complete resolution of clinical, radiological and mycological evidence
时间窗: 45 and 90 days
3.Improved: Resolution of clinical features, radiological regression
时间窗: 45 and 90 days
outcome of mucormycosis in India
时间窗: 45 and 90 days
次要结局
- Grade III and IV toxicities of antifungal agents(45 days)