EUCTR2014-005021-13-Outside-EU/EEA进行中（未招募）不适用
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 - Comparison Amphotericin B Liposome Neutropenic Pediatric Patients
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female patients are at least 2 years of age and less than 18 years of age at the time of initial screening.
- •Patient has received chemotherapy for leukemia, lymphoma, or other cancers or has undergone hematopoietic stem-cell transplantation.
- •Patient has had an absolute neutrophil count <500/µL for at least 96 hours (the patient must not be expected to recover from neutropenia in the next 48 hours), and has received at least 96 hours of parenteral broad spectrum systemic antibacterial therapy preceding randomization, and has fever >38.0°C within the last 24 hours prior to randomization. Appropriate antibiotics are those that provide broad spectrum Gram-positive and Gramnegative coverage.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 82
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient has an inadequately managed bacterial infection at the time of enrollment.
- •Patient has abnormal laboratory values: 1) Platelet count <5000/µL. 2) INR >1.6 (if patients are receiving anticoagulants, INR>4.0). 3) Bilirubin >3 times upper limit of normal for age. 4) AST (SGOT) or ALT (SGPT) >5 times the upper limit of normal for age.
- •Patient has a known documented invasive fungal infection at the time of enrollment.
研究者
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已完成
不适用
.A.PER-004-98MERCK SHARP & DOHME PERU S.R.L.,
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