CTRI/2024/04/065615尚未招募Unknown
A Prospective, Prescription Event Monitoring (PEM) surveillance of EMROK® &/or EMROK O® in the management of Diabetic Foot Infections.
Wockhardt Ltd1 个研究点 分布在 1 个国家目标入组 7,500 人开始时间: 2024年4月23日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 7,500
- 试验地点
- 1
- 主要终点
- 1. Evaluate safety profile of EMROK in patients with DFI
研究概览
简要总结
This is a prospective and multi-centric prescription event monitoring (PEM) surveillance in patients who have been prescribed with either EMROK® or EMROK O® or both. Eligible patients will be identified by the investigator / physician based on selection criteria. All the patients must have received EMROK® or EMROK O ® in routine clinical practice at the study site. Data would be collected from the medical records of such patients prospectively.
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
- •1.Subject any gender age 18 years or above.
- •subject must be willing to participate in the study and must provide written inform consent.
排除标准
- •subjects with history of hypersensitivity of drug or same class of drug.
结局指标
主要结局
1. Evaluate safety profile of EMROK in patients with DFI
时间窗: At day 4 and day 28 or EOT
2. Incidence of adverse events 3. Overall Global Assessment for Safety on 5 point Likert Scale
时间窗: At day 4 and day 28 or EOT
次要结局
- 1. Clinical Success Rate at EOT(2. Clinical Responder Rate / Clinical improvement rate at EOT)
研究者
Dr Vishal Dalvi
Vishal Clinic
研究点 (1)
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