CTRI/2010/091/000174已完成3 期
An open labeled, randomized, comparative study to evaluate efficacy and safety of fixed dose combination of Ceftriaxone + Sulbactam (CSE-1034) vs Ceftriaxone in subjects suffering from various bacterial infections.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 654
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male and female subjects in the age group of 12-65 years
- •Clinically diagnosed subjects with Urinary Tract Infection, Skin and skin structure infections, Bone and joint infections, Septicemia, Surgical prophylaxis, acute bacterial ottitis media, Meningitis,LRTI(Lower respiratory tract infections)
- •Adult patient willing to give written informed consent. Parent or LAR of minor patients ready to give written informed consent.
排除标准
- •History of hypersensitivity reaction or any specific contraindication to pencillin group of drugs or cephalosporins or ceftriaxone and sulbactam.
- •Presence of hepatic or renal disorder
- •History of hearing loss
- •Pregnant and lactating women
研究者
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