Comparative Study of Efficacy and Safety Between Combination of Colistin and Meropenem and Combination of Amikacin and Meropenem 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
- 100
- 试验地点
- 1
- 主要终点
- clinical cure at 72 hours
研究概览
简要总结
Objective of this study is to compare the efficacy and safety between combination of colistin and meropenem and combination of amikacin and meropenem for multi-drug-resistant gram-negative bacteria in Intensive Care Unit. In Beni- Suef University Hospital.
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
- •Study will include adult patient (male, female).
- •Patient age from 18 to 70 years.
- •Patient will be admitted to intensive care unit in study period (six months), who will receive intravenous colistin and meropenem or amikacin and meropenem as antimicrobial drug for treatment their MDR gram negative infection
排除标准
- •Patients are admitted to intensive care unit younger than 18 years or older than 70 years.
- •Patients are chronic kidney disease (CKD on hemodialysis or baseline creatinine clearance (crcl) < 10 ml/min (estimated by Cockcroft Gault equation).
- •Patients received renal replacement therapy before or during admission.
- •Patients are on any other nephrotoxic drug (vancomycin, NSAIDs, cyclosporine, amphotericin B, etc.)).
- •Pregnant and lactating women.
- •Patients refused the consent of the study.
研究组 & 干预措施
amikacin and meropenem
50 patients received intravenous amikacin 15 to 30 mg/kg once daily and intravenous meropenem 2gm every 8hrs
干预措施: Amikacin Injection and meropenem (Drug)
colistin and meropenem
50 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 and intravenous meropenem 2gm every 8hrs
干预措施: Colistimethate sodium for injection, meropenem (Drug)
结局指标
主要结局
clinical cure at 72 hours
时间窗: 72 hours
Number of participants achieving clinical cure, defined as resolution of fever and improvement of the baseline signs and symptoms of infection without the need to change or escalate antibiotic therapy.
Body temperature
时间窗: 72 hours
Body temperature measured at baseline and 72 hours after initiation of antibiotic therapy.
White blood cell count
时间窗: 72 hours
White blood cell (WBC) count measured at baseline and 72 hours after initiation of antibiotic therapy.
次要结局
- Serum creatinine level(72 hours)
- 14- day survival rate(14 days)
研究者
Asmaa Nafady Abdelfattah
pharmacist
Beni-Suef University