EUCTR2014-004041-26-Outside-EU/EEA进行中（未招募）不适用
A Phase I, open-label, multi-centre study to evaluate the PK and safety of solithromycin as add-on therapy to antimicrobial agent administered to paediatric subjects with a suspected or confirmed bacterial infection.
Cempra Pharmaceuticals , Inc0 个研究点目标入组 64 人开始时间: 2014年10月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
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
- •1. <18 years of age
- •2. Suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 64
- •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
- •1. Serum creatinine >2 mg/dL
- •2. Hepatic dysfunction – ALT or AST >3x ULN or direct bilirubin >ULN
研究者
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