Observational, Retrospective Study to Evaluate the Clinical Outcome in High Risk Patients Who Received Empirical Antifungal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean Duration of ICU (Intensive Care Unit) / HDU (High Dependency Unit stay after initiation of Antifungal Therapy
研究概览
简要总结
Retrospective, observational study To study the effect of Empirical Antifungal therapy on clinical outcome in high risk patients with suspected Invasive Fungal Infection admitted in ICU/Critical care unit, To know the current epidemiology of IFI and management approach in patients at high risk of Invasive fungal infections, Identify the risk factors associated with Invasive fungal infections, To comment on the appropriateness of empirical therapy used based on proven/probable diagnosis
详细描述
Study Objectives
Primary Objective:
- To study the effect of Empirical Antifungal therapy on clinical outcome in high risk patients with suspected Invasive Fungal Infection admitted in ICU/Critical care unit
- Secondary Objectives:
- To know the current epidemiology of IFI and management approach in patients at high risk of Invasive fungal infections
- Identify the risk factors associated with Invasive fungal infections
- To comment on the appropriateness of empirical therapy used based on proven/probable diagnosis
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Non-neutropenic patients (18-75yrs) admitted in the intensive care/critical care unit who are prescribed any form of pre-emptive / empirical Antifungal therapy during the specified study duration period
排除标准
- •Neutropenic patients
- •Patients with proven invasive fungal infections where antifungal therapy was initiated after the confirmation of Invasive fungal infection/Candidemia
- •Patients who received prophylactic antifungal agents
结局指标
主要结局
Mean Duration of ICU (Intensive Care Unit) / HDU (High Dependency Unit stay after initiation of Antifungal Therapy
时间窗: 6 months
Mortality both Short term (while on antifungal therapy) and Long term (within 12 weeks of completion of antifungal therapy)
时间窗: 6 months
次要结局
- The risk factors in patients with proven/probable invasive fungal infections(6 months)
- The appropriateness of antifungal agent based on microbiological and/or clinical outcome(6 months)
- The common pathogens associated with Invasive Fungal Infections(6 months)
- The common empirical antifungal agents used in suspected Invasive Fungal Infection(6 months)
- The mean time for initiation of Antifungal therapy after suspicion of invasive fungal infection(6 months)
研究者
Dr Raja Dhar
Consultant Pulmonologist
Fortis Hospital, India