A multicentre,single blind, comparative clinical trial to compare the efficacy and safety of FDC of cefoperazone and tazobactam and cefoperazone alone in infections caused by Gm(-ve) organisms.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Clinical improvement and bacteriological conversion(when applicable) are the primary outcome and are defined as a subject who is -afebrile for 48 hours.-Improvement of X-ray lesion in lower respiratory tract infection as compared to pretreatment.-Isolation tests show the reduction or absence of infecting organisms detected in initial cultures on 48 hours, 7 days, 14 days of treatment and again 7 days after discontinuation of injectable antibacterial treatment.
研究概览
简要总结
This study is a comparative, Single blind, multi-centre trial, comparing the safety and efficacy of FDC containing cefoperazone & tazobactam and cefoperazone alone twice daily for 7-14 days in 200 patients with infections caused by Gm (-ve) organisms that will be conducted in four centers in India. The primary outcome measures will be clinical improvement and bacteriological conversion (when applicable). The secondary outcome will be complete resolution of all symptoms of infections.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects in the aged group of 18-60 years shall be selected.
- •Clinically diagonised subjects with gm (-ve) infections with culture showing the organisms.
- •Subjects willing to give informed consent.
- •Patient must not have received any antibiotics in previous 4 weeks.
排除标准
- •History of hypersensitivity reaction or any specific groups.
- •Presence of severe hepatic or renal disorders.
- •Pregnancy or lactation.
- •History of hearing loss.
- •Previous history seizure.
结局指标
主要结局
Clinical improvement and bacteriological conversion(when applicable) are the primary outcome and are defined as a subject who is -afebrile for 48 hours.-Improvement of X-ray lesion in lower respiratory tract infection as compared to pretreatment.-Isolation tests show the reduction or absence of infecting organisms detected in initial cultures on 48 hours, 7 days, 14 days of treatment and again 7 days after discontinuation of injectable antibacterial treatment.
次要结局
- The time for complete resolution defined as -complete resolution of all symptoms of infection.-The number of days after beginning treatment with FDC of cefoperazone & tazobactam or cefoperazone alone to discharge.