NCT00836875终止3 期
A Prospective, Open-label, Non-randomized, Multi-center Study To Investigate The Safety And Tolerability Of Voriconazole As Primary Therapy For Treatment Of Invasive Aspergillosis And Molds Such As Scedosporium Or Fusarium Species In Pediatric Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 31
- 试验地点
- 24
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety profile of voriconazole (an antifungal drug) when used in children who have invasive aspergillosis (IA) and other rare systemic fungal infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Immunocompromised with clinically compatible illness.
- •Diagnosis of proven or probable or possible Invasive Aspergillosis (based on a modified version of the revised EORTC/MSG consensus definitions).
- •Diagnosis of infection due to Scedosporium or Fusarium species.
- •Male and female from 2 to 17 years of age.
- •Females with childbearing potential must have negative pregnancy test and be using appropriate contraception.
排除标准
- •Allergy or hypersensitivity to the azole drugs.
- •Female subjects who are pregnant or lactating.
- •Patients who received more than four days of antifungal drugs to treat the current episode of invasive aspergillosis or rare mold infection.
- •Received within 24 hours prior to enrollment drugs that may cause QT interval prolongation.
- •Significant liver, kidney or heart dysfunction.
- •Not expected to survive for at least 5 days.
研究组 & 干预措施
1
Experimental
Children from 2 to 17 years who have possible, probable or proven invasive aspergillosis, or other rare mold infection (eg, Scedosporium and Fusarium).
干预措施: Voriconazole (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment
次要结局
- Time to Death(Baseline up to 1 month post treatment)
- Percentage of Participants With a Global Response of Success(Weeks 6 and End of Treatment (EOT; up to Week 12))
- All-Cause Mortality - Number of Participant Deaths(Week 6 and EOT (up to Week 12))
- Attributable Mortality - Number of Participant Deaths(Weeks 6 and EOT (up to Week 12))
研究者
研究点 (24)
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