Non-interventional Study on the Safety and Efficacy for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 16
- 主要终点
- Safety assessed by AEs of special interest (stratified by relationship to micafungin treatment)
研究概览
简要总结
The aim of the study is to prospectively evaluate the safety and efficacy of micafungin when prescribed for prophylaxis or treatment of fungal infections in different real-world clinical conditions and centers, in pediatric patients in Asia/Oceania.
详细描述
The study will collect safety and efficacy data from pediatric patients who are prescribed intravenous micafungin for prophylaxis. During this trial, patients with two separate indications will be treated. The first, Invasive candidiasis will have a minimum treatment of 2 weeks. The second, Oesophageal candidiasis will have a minimum treatment of 1 week. Both indications will have a follow-up period of 4 weeks after treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prescribed micafungin for prophylaxis or treatment of fungal infections.
- •According to treatment guidelines, micafungin may not be a suitable treatment for the following patients:
- •The patient has evidence of impaired liver function: alanine aminotransferase (AST), aspartate aminotransferase (ALT) >5 times the upper limit of normal (ULN) or total bilirubin >2 times ULN.
- •The patient has a history of allergy, hypersensitivity, or any serious reaction to the echinocandin class of antifungals.
- •The patient has a confirmed systemic fungal infection with a non-Candida species.
排除标准
- •The patient is receiving micafungin treatment in combination with other antifungal drugs.
研究组 & 干预措施
Treatment: micafungin
Participants receive once daily by intravenous infusion.
干预措施: Micafungin (Drug)
结局指标
主要结局
Safety assessed by AEs of special interest (stratified by relationship to micafungin treatment)
时间窗: Up to end of trial (up to 95 weeks)
This includes hepatic dysfunction, renal dysfunction, infusion-related reactions, haemolytic events, histamine-release/allergic-type reactions and injection site reactions
Incidence and severity of Adverse Drug Reactions (ADRs) collected during the observational period
时间窗: Up to end of trial (up to 95 weeks)
ADR is considered to be any noxious and unintended response associated with the use of a drug in humans, at any dose, where a causal relationship (drug-event) is at least a reasonable possibility
Safety assessed by incidence of Serious Adverse Events (SAEs)
时间窗: Up to end of trial (up to 95 weeks)
Adverse event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event
Safety assessed by vital sign measurements
时间窗: Up to end of trial (up to 95 weeks)
Vital sign measurements include systolic and diastolic blood pressure, pulse rate, and body temperature
Incidence of death attributable to micafungin treatment
时间窗: Up to end of trial (up to 95 weeks)
Death, if considered by the clinician to be attributable to micafungin
次要结局
- Change from baseline to end of treatment in safety laboratory parameters(Up to end of trial (up to 95 weeks))
- Safety assessed by nature, frequency and severity of Adverse Events (AEs)(Up to end of trial (up to 95 weeks))
- Overall treatment success(Up to end of trial (up to 95 weeks))
- Mycological response at end of treatment in patients with proven invasive fungal infection with candida or aspergillus species(Up to end of trial (up to 95 weeks))