A Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Versus (Amphotericin B) Liposome for Injection as Empirical Therapy in Pediatric Patients With Persistent Fever and Neutropenia

Merck Sharp & Dohme LLC0 个研究点目标入组 100 人开始时间: 2004年4月最近更新: 2017年2月23日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 100
主要终点: To estimate the proportion of patients treated with caspofungin reporting one or more clinical and/or laboratory drug-related adverse experience(s) during the study drug therapy period plus 14 days posttherapy

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study is a double-blind, randomized study of MK0991 versus liposomal amphotericin B in the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute neutrophil count (ANC) below 500/microliter and who have fever despite broad antibiotic coverage. Such patients would be candidates for empirical therapy with an intravenous anti-fungal agent.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Double (Participant, Investigator)

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

•Patients who are 2 through 17 years of age
•Absolute Neutrophil Count (ANC) is below 500/microliter
•Have persistent fever (at least 4 days) despite antibiotic therapy

排除标准

未提供

结局指标

主要结局

To estimate the proportion of patients treated with caspofungin reporting one or more clinical and/or laboratory drug-related adverse experience(s) during the study drug therapy period plus 14 days posttherapy

次要结局

Proportion of patients with a favorable overall response

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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