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 Community Acquired Bacterial Pneumonia (CABP).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 107
- 试验地点
- 12
- 主要终点
- 1. Clinical Response
研究概览
简要总结
This is Prospective, Open label, Singlearm, Multi-centric, Investigator initiated study.
This study aims to evaluate efficacyand safety of Levonadifloxacin (IV And Oral) in patients of Community AcquiredBacterial Pneumonia (CABP).
Duration of treatment will be 5-7 days.(Duration of treatment can be extend upto 14 days in concurrent bacteremia asper investigator’s discretion.)
Primary endpoint - Clinical Response ina subject is defined as: Cure, failure and Indeterminate
Microbiological response is defined as: Cure, failure and Indeterminate
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 Community Acquired Bacterial Pneumonia (CABP) 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. Clinical response on Day 4, EOT (End of Treatment) and TOC (Test of Cure) | 2. Microbiological response on EOT (End of Treatment)
2. Microbiological Response
时间窗: 1. Clinical response on Day 4, EOT (End of Treatment) and TOC (Test of Cure) | 2. Microbiological response on EOT (End of Treatment)
次要结局
- Incidence of adverse events(Incidence of serious adverse events)