A prospective Prescription Event Monitoring (PEM) surveillance to study the safety and efficacy of Emrok (Levonadifloxacin injection) and or Emrok O (Levonadifloxacin Tablet).
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- 1. Overall Global Assessment for Safety.
研究概览
简要总结
This will be a prospective and multi-centric prescription event monitoring (PEM) surveillance in patients who have prescribed with either EMROK® or EMROK O® or both. Eligible patients will be identified by the investigator / physician based on inclusion and exclusion criteria. All the patients must have received EMROK® or EMROK O ® in routine clinical practice at the study site.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to give inform consent.
- •Require Emrok treatment.
排除标准
- •Pregnant and lactating women.
结局指标
主要结局
1. Overall Global Assessment for Safety.
时间窗: Visit 1,visit 3 and Visit 8 or or as per PI discretion.
2. Incidence of adverse events.
时间窗: Visit 1,visit 3 and Visit 8 or or as per PI discretion.
3.Evaluate the safety profile of EMROK® &/or EMROK O®
时间窗: Visit 1,visit 3 and Visit 8 or or as per PI discretion.
次要结局
- Clinical Response at early assessment(Day)
- Clinical Success Rate(At EOT/ day 8±2/PI discretion)
- Microbiological Success Rate(EOT/ day 8±2 or as per the PI discretion.)
- Overall Global Assessment for Efficacy(EOT/day 8±2 or as per the PI discretion)
- Usage of EMROK® &/or EMROK O® treatment(EOT/day 8±2 or as per the PI discretion)
研究者
Dr Yogesh Kumar Sharma
Aryan clinic Consulting Physician