International Pediatric Fungal Network: Multi-Center Studies to Improve Diagnosis and Treatment of Pediatric Candidiasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 750
- 试验地点
- 35
- 主要终点
- Global response to antifungal therapy
研究概览
简要总结
The overarching objective is to develop new evidence-based treatment guidelines for invasive fungal diseases in children. To accomplish that, this protocol will focus on two specific aims: 1) Compare the effectiveness of echinocandin versus amphotericin B or triazole antifungal therapy for pediatric invasive candidiasis and for the subset of patients with invasive candidemia; 2) Characterize the incidence rate of inpatient pediatric invasive candidiasis per hospital admissions.
详细描述
This study is a multicenter, national and international, prospective observational comparative effectiveness study.
The primary aim of this study is to compare the effectiveness of echinocandin versus amphotericin B or triazole antifungal therapy for pediatric invasive candidiasis and for invasive candidemia. The primary effectiveness endpoint for study aim 1 is the comparison of global response at 14 days of antifungal therapy between antifungal therapeutic classes. The secondary effectiveness endpoints for study aim 1 are comparative effectiveness of the 1) global response to antifungal therapy after 30 days and 2) all-cause mortality at 30 days.
The secondary aim is to characterize the frequency of pediatric candidiasis by describing the incidence of pediatric candidiasis relative to all pediatric admissions. For this aim, the investigators will use descriptive statistics to establish the frequency of hospital admissions involving an invasive candidiasis per total hospital admissions and total hospital days during the study period.
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
- 120 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females age > 120 days and <18 years
- •Documented proven or probable case of invasive candidiasis
- •Parental/guardian permission (informed consent, if required) and if appropriate, child assent (if required).
排除标准
- •Any history of prior Candida infection within the previous 35 days (These patients will not be eligible for analysis in aim 1 but will be eligible for inclusion of aim 2)
研究组 & 干预措施
Pediatric Invasive Candidiasis
Pediatric patients (age > 120 days and < 18 years) with documented proven or probable invasive candidiasis
干预措施: Observational antifungal therapy (Drug)
结局指标
主要结局
Global response to antifungal therapy
时间窗: 14 days
次要结局
- Global response of antifungal therapy(30 days)
- All-cause mortality(30 days)