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
- 发起方
- 入组人数
- 500
- 试验地点
- 13
- 主要终点
- Mortality
研究概览
简要总结
This is an observational chart review of all patients with confirmed and probable diagnosis of mucormycosis at 19 centers across Indian hospital. Data will collect using a standardized CRF. All collected data will be entered into a database prior to analysis. Broadly data will be collected on demography, clinical characteristics, diagnosis, treatment and outcome for each patient. Patient will continue to receive treatment as per treating physicians advise. Primary outcome for this study will be overall survival at 45 & 90 days.
详细描述
Introduction
Mucormycosis is a life threatening angio-invasive fungal infection generally occurring in immunocompromised individuals. In recent years the incidence has increased globally and alarmingly in India especially in patients with uncontrolled diabetes. Mucormycosis is associated with very high morbidity and mortality. Mortality can be reduced with increased awareness of the disease, and aggressive medical and surgical intervention. Though few case series of mucormycosis are published from India, multiple gaps in knowledge exist regarding epidemiology, diagnosis and management of the disease in this country. It is therefore proposed to conduct this multicentric observational study in India to evaluate epidemiology, mode of diagnosis, management practices and outcome in patients with mucormycosis.
Study Objectives
Primary:
- To describe the epidemiology, diagnosis, treatment practices and outcome of mucormycosis in India
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive patients regardless of age with a confirmed diagnosis mucormycosis through HPE & /or culture will be enrolled in this study. In suspected cases on histopathology, molecular technique of extraction of DNA from tissue and sequencing to identify the pathogen, will be used to confirm the diagnosis
- •All probable cases of mucormycosis.
排除标准
- 未提供
结局指标
主要结局
Mortality
时间窗: Three months after the completion of the study
Number of deaths
次要结局
未报告次要终点
研究者
Arunaloke Chakrabarti
Chairman FISF
Fungal Infection Study Forum