An open labeled, randomized, comparative study to evaluate the Efficacy and Safety of Etimicin Sulphate v/s Amikacin in patients suffering from various bacterial infections
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- To evaluate the Efficacy of Etimicin Sulphate vs Amikacin in patients suffering from various bacterial infections
研究概览
简要总结
This an open labeled, randomized, comparative study to evaluate efficacy and safety of test drug (Etimicin Sulphate) vs Amikacin sulphate. A total of 200 patients which lies in the age group of 18 to 60 years and are suffering from various bacterial infections will be enrolled at this multi centric two arm comparative phase-3 trial. In arm A 100 patients will be treated with Etimicin 4.5mg/kg/day while another 100 patients (Arm B) will receive treatment of Amikacin 15 mg/kg/day divided into 2 or 3 equal doses administered at equally-divided intervals. The primary objective is to establish the efficacy of test drugs , while secondary objectives of the study is to confirm the safety of both the drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects in the age group of above 18 years till 60 years shall be selected.
- •Presence of an abnormal chest x-ray (CXR) as determined by the primary care team in case of LRTI patients Clinically diagnosed subjects with Respiratory tract infections mainly LRTI (Lower respiratory tract infections) , skin & skin structure infections, UTI (Urinary tract infections), surgical infections Patients or legal guardian or LAR (Legally acceptable representative) ready to give written informed consent.
排除标准
- •History of hypersensitivity reaction or any specific contraindication to Aminoglycosides or Etimicin or AmikacinPresence of hepatic or renal disordersHistory of hearing lossPregnant or lactating women.
结局指标
主要结局
To evaluate the Efficacy of Etimicin Sulphate vs Amikacin in patients suffering from various bacterial infections
时间窗: nil
次要结局
- To evaluate the Safety and tolerability of Etimicin Sulphate vs Amikacin in patients suffering from various bacterial infections