NCT01092832终止3 期
A Prospective, Open-label, Non-comparative Study To Assess The Safety, Tolerability And Efficacy Of Voriconazole For The Primary And Salvage Treatment Of Invasive Candidiasis, Candidemia, And Esophageal Candidiasis In Pediatric Subjects
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
- 23
- 试验地点
- 14
- 主要终点
- Percentage of Participants With Adverse Events - Overall Summary
研究概览
简要总结
The purpose of this study is to determine whether voriconazole is safe and effective for the treatment of serious Candida infection and Candida infection of the esophagus in children and adolescents.
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
- •Male or female 2 to <18 years of age; Subjects 2 to <12 years of age will be permitted to enroll in this study only after a Pfizer sponsored pharmacokinetic study confirms the proposed dosage corresponding to this age group is appropriate.
- •Patients with confirmed Candida infection of the blood, body tissues, or the esophagus.
- •Patient's doctor feels voriconazole is an appropriate choice of therapy.
排除标准
- •A known allergy to voriconazole or to azole to antifungal drugs.
- •Females who are pregnant, lactating (breast feeding) or planning a pregnancy during the course of the study, or who are of childbearing potential and not using highly effective method of birth control.
- •A patient who is receiving treatment with a drug know to interfere with the heart's electrical system (QTc prolongation).
- •A patient who is receiving treatment with a drug that is not permitted to be used with voriconazole.
- •For primary therapy: a patient who has received more than 48 hours of antifungal therapy for the current episode of Candida infection.
- •A patient with significant underlying liver disease at the time of enrollment in the study.
- •A patient with significant renal disease (CrCl < 50 ml/min) at the time of enrollment in the study.
- •A patient with a high likelihood of death within 72 hours of study enrollment due to factors unrelated to Candida infection.
研究组 & 干预措施
Active voriconazole
Experimental
All subjects in this study will receive active voriconazole in an open-label fashion; there is no comparator in this study.
干预措施: voriconazole (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events - Overall Summary
时间窗: Baseline up to 1 month follow-up
Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, who discontinued due to AEs, or who had dose redued or temporarily discontinued due to AEs.
次要结局
- Percentage of Participants With a Global Response of Success at End of Treatment (EOT)(EOT (from 7 to 42 days of treatment))
- All-Cause Mortality - Number of Participant Deaths(Day 28 and 1 Month Follow-up)
- Time to Death(Baseline up to 1 month follow-up)
研究者
研究点 (14)
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