EUCTR2014-004911-35-Outside-EU/EEA进行中（未招募）不适用
A Multicenter, Open-Label, Noncomparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in Children with Documented Candida or Aspergillus Infections - Documented Candida or Aspergillus Infections in Pediatric Patients
适应症
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
- 50
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
- •The patient is at least 3 months of age and younger than 18 years of age at time of study drug administration.
- •Clinical evidence of infection must be present at some time within 48 hours prior to enrollment.
- •Inclusion Criteria for Patients With Aspergillus Infections: 1) Patients must meet definitions of proven or probable invasive aspergillosis (as specified in criteria developed by the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Co- Operative Group (EORTC/IFICG) and the National Institute of Allergy and Infectious Diseases - Mycoses Study Group (NIAID-MSG)
- •Inclusion Criteria for Patients With Esophageal Candida Infections, Patients with a diagnosis of esophageal candidiasis based on symptoms, endoscopy and microbiology or histopathology for whom IV therapy is appropriate.
- •Inclusion Criteria for Patients With Invasive Candida Infections, Patient must have at least 1 positive culture of a Candida species from blood or other normally sterile body site, which has been obtained within 4 days of study entry.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 49
- •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 is <3 months or =18 years of age (at time of the first dose of study drug administration).
- •Patient has any of the following abnormal laboratory values: a) International normalization ratio (INR) >1.6 or, if patient is receiving anticoagulants, INR >4.0. b) Bilirubin >3 times the upper limit of normal for age. c) AST (SGOT) or ALT (SGPT) >5 times the upper limit of normal for age. d) Platelet count <5000/µL.
研究者
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