Comparison of efficacy, safety, pharmacokinetic and pharmacodynamic parameters between conventional dosing regimen of vancomycin with novel optimized dosing regimen in critically ill patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving AUC 0-24 hours/MIC ratio more than 400 in both the treatment groups.
研究概览
简要总结
A study to compare efficacy, safety, pharmacokinetic and pharmacodynamic parameters between conventional dosing regimen and optimised or alternate dosing regime in critically ill patients is planned to be carried out in our institute. We are comparing 1gram twice daily with 500 milligram four times daily. Vancomycin when administered at a dose of 1 gram twice daily may not reach adequate therapeutic concentration in serum as has been shown by a previous study done in our institute. So by this study we are planning to estimate the target concentration attainment of vancomycin in blood and to check if it leads to therapeutic efficacy, reduced mortality, reduction in treatment failure. The study is planned as a two arm parallel open label randomised control trial followed by single arm validation study. The allocation ratio is 1:1. The study will be conducted in Intensive care unit and Emergency wards in PGIMER, Chandigarh. The ethical clearance for this study has been obtained. Informed consent will be taken from the patients or legal attendants before enrolment in the study.
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Critically ill adults admitted to intensive care unit or emergency ward where intravenous vancomycin therapy is deemed necessary based on suspected or confirmed infectious aetiology.
排除标准
- •Patients less than 18 years.
- •Patients requiring renal replacement therapy.
- •Patients with end stage renal disease.
- •Patients with end stage hepatic failure.
- •Any contraindication or history of hypersensitivity with use of vancomycin.
- •Pregnant and lactating women.
结局指标
主要结局
Proportion of patients achieving AUC 0-24 hours/MIC ratio more than 400 in both the treatment groups.
时间窗: Time points considered will be 15 minutes, 30 minutes, 2 hours, 6 hours, 23.5 hours after administration of dose.
次要结局
- Proportion of patients alive at Day 28 in the treatment groups.(At the end of 28 days.)
- Proportion of patients requiring substitution of or addition to vancomycin with other antibiotics for the same indication.(5 days of therapy.)
- Number of days from vancomycin initiation to intensive care unit discharge.(5 days of therapy.)
- Duration of vasopressor support.(5 days of therapy.)
- Proportion of patients achieving trough concentration of 15-20 in both the treatment groups.(Second day after starting therapy.)
- Proportion of patients alive at the end of treatment in both the treatment groups.(5 days of therapy.)
- Proportion of clinical failure at the end of treatment in both the treatment groups.(5 days of therapy.)
- To compare the frequency of patient readmission between the treatment groups.(At the end of 28 days.)