A Prospective, Prescription Event Monitoring (PEM) of NUWOK® (Levonadifloxacin injection) and/or NUWOK-O® (Alalevonadifloxacin tablet) to evaluate the safety and effectiveness in real-world setting
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- 1 Understanding the prescription pattern of NUWOK in orthopedic setting
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 NUWOK® or NUWOK O® or both either for prophylactic use in bone & joint surgery OR as a post-operative prophylaxis OR as a treatment for prosthetic joint infection, osteomyelitis or any kind of bone and joint infection . Eligible patients will be identified by the investigator / physician based on selection criteria. All the patients must have received NUWOK® or NUWOK 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
- •Patient age 18 years or above 18 years.
- •willing to patriciate in the study and provide inform consent.
- •Patients diagnosed with bone and joint infection.
排除标准
- •patients with history of hypersensitivity of drug and same class of drug.
结局指标
主要结局
1 Understanding the prescription pattern of NUWOK in orthopedic setting
时间窗: day 4 and day 28 or EOT
2 Evaluate safety profile of NUWOK in patients under orthopedic setting
时间窗: day 4 and day 28 or EOT
3 Incidence of adverse events
时间窗: day 4 and day 28 or EOT
4 Overall Global Assessment for Safety
时间窗: 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 Yogesh Vaidya
Pinnacle Ortho Centre Hospital