Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline for Multi-Drug Resistant Gram Negative Bacteria
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- comparison clinical success between colistin and tigecycline
研究概览
简要总结
Objective from this study to compare the clinical outcomes and safety between colistin and tigecycline for multi-drug resistant gram negative bacteria.
详细描述
Study will be in Beni-Suef university hospital. Group I: 66 patients received intravenous colistin 300 mg colistin base activity (CBA) as loading dose, followed by 2.5-5mg/kg/day of CBA in 2 divided doses as a maintenance dose in intensive care unit to treat their MDR infection and group 2 contains 66 patients received intravenous tigecycline100 mg single dose as loading dose, followed by 25-50 mg every 12 hours maintenance dose in intensive care unit to treat their MDR infection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Colistin
Intravenous colistin 300 mg colistin base activity (CBA) as loading dose, followed by 2.5-5mg/kg/day of CBA in 2 divided doses as a maintenance dose.
Reconstitute each vial of CBA with 2 ml of sterile water for injection, swirl gently. further dilute in normal saline.
干预措施: Colistimethate Sodium (Drug)
Tigecycline
intravenous tigecycline100 mg single dose as loading dose, followed by 25-50 mg every 12 hours maintenance dose.
add 5.3 ml normal saline to each 50 ml vial. swirl gently. further dilution to final concentration does not exceed 1mg/ml.
干预措施: Tigecycline (Drug)
结局指标
主要结局
comparison clinical success between colistin and tigecycline
时间窗: 6 months
the disappearance of clinical signs and symptoms as normalization of leukocyte counts and resolution of fever after receiving colistin and tigecycline
次要结局
未报告次要终点
研究者
Nada Abd El-Hamed Saad Rezk
Pharmacist
Beni-Suef University