Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection In Preterm Neonates: A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- resolution of fungal infection
研究概览
简要总结
The incidence of fungal infection has increased dramatically over the past few decades.This is due to increase in survival rates of preterm neonates, advances in medical technology and drug therapy, broad spectrum antibiotics and parenteral nutrition . The resistance to antifungal agents has increased. This study will assess the efficacy of micafungin versus amphotericin B in neonates with positive fungal culture.
详细描述
Neonatal candidiasis is associated with significant mortality and morbidity and high rates of neuro-developmental impairment on follow up Prevalence of invasive fungal infection (IFI) has increased in neonates during the last two decades due to increased survival rate even in the extremely premature neonates. Candida albicans and Candida parapsilosis are responsible for the majority of candidiasis in the neonatal intensive care unit (NICU) According to the European Society for Clinical Microbiology and Infectious Diseases (ESCMID)guidelines published in 2012, Micafungin, amphotericin B deoxycholate, and fluconazole are recommended as first line treatment of invasive candidiasis in neonates Currently, fluconazole and micafungin are among the most frequently used antifungal agents for the treatment of neonatal invasive candidiasis High dose of micafungin (8 to 15 mg/kg/day) can be used with neonates and infant with invasive candidiasis In this study we will explore the effectiveness and safety of micafungin for treatment of candidiasis after fluconazole for preterm neonates with invasive fungal infection and to compare it with amphotericin B.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomized controlled, Double Blinded Clinical Trial.
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient less than 36 weeks gestational age
- •started fluconazole either prophylactic or therapeutic dose
- •and blood culture is positive for fungal infection.
排除标准
- •Any neonate with hepatic dysfunction for any cause (hepatitis or hepatic failure), or with elevation in AST, ALT, alkhaline phosphatase
- •Any neonate hypertensive, neutropenic, thrombocytopenic
- •Any neonate with elevated renal function
- •Any neonate with arrythmia
研究组 & 干预措施
micafungin group
Preterm neonate with fungal infection provened by fungal culture and who received fluconazole for at least one week will be divided into two groups. Will receive micafungin at a dose of 8 mg/kg/day for 14 day (Auriti et al., 2016).
干预措施: Micafungin (Drug)
amphotericin B group
Preterm neonate with fungal infection provened by fungal culture and who received fluconazole for at least one week will be divided into two groups. Will receive amphotericin B at a dose of 1 mg /kg/day for 14 days (chen et al.,2019).
干预措施: Amphotericin B (Drug)
结局指标
主要结局
resolution of fungal infection
时间窗: 14 days
negative blood culture
次要结局
- complication(one month)
- morbidity(one month)
- mortality(one month)
研究者
Mariam Ibrahim
Assistant Professor of Paediatrics, Ain Shams university
Ain Shams University