NCT05862402招募中4 期
Dose Optimization by PK/PD of Antibiotics to Improve Clinical Outcome of CRKP Bloodstream Infections in Critically Ill Patients and in Vitro Study of Monotherapy, Combination Therapy and Molecular Biology of Drug Resistance at Phramongkutklao Hospital: Prospective, Historical Controlled Study
Phramongkutklao College of Medicine and Hospital1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年5月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The patients who infected with Carbapenem resistant Klebsiella pneumoniae were high mortality rate. Appropriate antibiotics therapy adjusted by Pharmacokinetic/Pharmacodynamic plays an important role in determining outcomes in Critically ill patients. Consequently, standard antibiotics dose may not be adequate to achieve pharmacokinetic/pharmacodynamic target in Critically ill patients. The purpose of this study is to compare the clinical outcomes between the critically ill patients who received antibiotics dose adjusted by pharmacokinetic/pharmacodynamic using Monte Carlo simulation and historical critically ill patients who received antibiotics from standard practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years and older who admitted at Phramongkutklao Hospital
- •Patients who was diagnosed blood stream infection with CRKP between April 10th, 2023 to March 31st, 2024 (Prospective study) and January 1st, 2012 to March 31st, 2023 (Retrospective study); Historical group
- •Patients who had signs and symptoms at least 1 criteria following:
- •Patients who had signs and symptoms of Systemic Inflammatory Response Syndrome (SIRS) at least 2 criteria:
- •Temperature above 38 oC or below 36 oC
- •Heart rate more than 90 beats/min
- •Respiratory rate more than 20 /min or PaCO2 less than 32 mmHg (4.3 kPa)
- •White blood cell more than 12,000 cell/mm3 or less than 4,000 cell/mm3 3.
- •Patients who was diagnosed sepsis or SOFA score or qSOFA score at least 2 score 3.
- •Patients who was diagnosed septic shock or who had hypotension with adequate fluid and need for vasopressor to maintain mean arterial pressure over 65 mmHg and serum lactate above 2 mmol/L
- •Patients who received antibiotics at least 48 hours which are as follow:
- •Ceftazidime-Avibactam or
- •Combination antibiotics (eg. Meropenem-Colistin, Imipenem-Colistin, Tigecycline-Amikacin, Tigecycline- Gentamicin, Tigecycline-Meropenem or Tigecycline-Colistin)
排除标准
- •Patients who were pregnancy or breastfeeding
- •Patients who had drug allergy (eg. Ceftazidime-Avibactam, Tigecycline, Amikacin, Gentamicin, Imipenem, Meropenem or Colistin)
- •Patients who not to received resuscitation.
- •Patients who were end stage cancer.
研究组 & 干预措施
Intervention group
Experimental
Dose antibiotics adjusted by pharmacokinetic and pharmacodynamic using Monte Carlo simulation
干预措施: Dose-adjustment by PKPD (Drug)
结局指标
主要结局
Mortality
时间窗: 14 day
Alive or death
次要结局
- Mortality(30 days)
- Duration of ventilator(Assessed with in 30 days)
- Ventilator free day(30 days)
- Vasopressor or Inotropic drug free day(30 days)
- Microbiological cure rate(14 days)
- Hospital length of stay(With in 30 days)
- ICU length of stay(With in 30 days)
- Clinical cure rate(Through treatment completion or with in 30 days)
- Duration of vasopressor or Inotropic agents(With in 30 days)
- Procalcitonin(14 days)
- Adverse event(Day 0, 5, 7 and finish course of Antibiotics or discharge)
研究者
研究点 (1)
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