CTRI/2020/11/029358招募中不适用
A Prospective, Open label, Single arm, Multi-centric, Investigator initiated study (IIS) for evaluation of efficacy and safety of Levonadifloxacin (IV And Oral) in patients of gram positive Bacteremia (Investigator Initiated Study)
Dr Yatin Mehta11 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2020年11月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 11
- 主要终点
- 1. Clinical Response
研究概览
简要总结
This is Prospective, Open label, Single arm, Multi-centric, Investigator initiated study.
This study aims to evaluate efficacy and safety of Levonadifloxacin (IV And Oral) in patients of gram positive Bacteremia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult subjects with 18 years and above of age
- •Subjects must be willing to participate in the study and provide a written informed consent
- •Patient diagnosed with gram positive Bacteremia and to be treated with Levonadifloxacin (IV or Oral) as per investigator’s discretion.
排除标准
- •1.Subjects with history of hypersensitivity to any of the study drugs or same class of drugs 2.Subjects who received any experimental drug within 30 days prior to enrolment 3.Subjects who, in the judgment of the Investigator, are likely to be noncompliant or uncooperative during the study 4.Subjects with any abnormality that the Investigator deems to be clinically relevant, either on medical history, systemic examination or ECG.
结局指标
主要结局
1. Clinical Response
时间窗: 1. Day 4, EOT (End of Treatment) and TOC (Test of Cure) | 2. EOT End of Treatment)
2. Microbiological Response
时间窗: 1. Day 4, EOT (End of Treatment) and TOC (Test of Cure) | 2. EOT End of Treatment)
次要结局
- Incidence of adverse events(Incidence of serious adverse events)
研究者
研究点 (11)
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