Management of Ventilation Acquired Pneumonia Caused by Pseudomonas and Acinetobacter Organisms in a Pediatric Center: a Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Antimicrobial susceptibility
研究概览
简要总结
The goal of this clinical trial is to determine the most effective empirical therapy of antibiotics for better ventilator-associated pneumonia control. The main question it aims to answer is:
• Which is better for clinical response single or combination empiric antibiotic therapies ?
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
- 1 Month 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ranging from one month to twelve years old, who had been undergoing mechanical ventilation for over 48 hours and were diagnosed with Ventillator Associated Pneumonia.
排除标准
- •Patients with pneumonia prior to mechanical ventilation initiation.
- •Patients who had been intubated for more than 24 hours before admission to the PICU, or those transferred from other PICUs and were already receiving antibiotic therapy.
研究组 & 干预措施
extended meropenem infusion in combination with other options
a) Patients treatment was modified to extended meropenem infusion in combination with other options such as Polymyxin, Tigecycline, Ertapenem, or Amikacin
干预措施: extended meropenem infusion in combination with other options such as Polymyxin, Tigecycline, Ertapenem, or Amikacin. (Combination Product)
two β-lactam antibiotics plus a single non-β-lactam antibiotic
b) Patient treatment was adjusted to include two β-lactam antibiotics plus a single non-β-lactam antibiotic, or a combination of double β-lactam antibiotics, with the aim of avoiding aggressive and toxic antibiotics
干预措施: two β-lactam antibiotics plus a single non-β-lactam antibiotic (Combination Product)
c) Patients treatment was adjusted to the second-line empirical antibiotic
c) Control group in which patients treatment was adjusted to the second-line empirical anti-biotic according to the hospital's local policy.
干预措施: Control group received standard therapy (Other)
结局指标
主要结局
Antimicrobial susceptibility
时间窗: 7 days
Antimicrobial susceptibility was assessed through Kirby-Bauer's disc diffusion method (DD), Minimal Inhibitory Concentration (MIC) using the automated VITEK 2 compact system (bioMérieux, France), and the Ameri-Ziaei Double Antibiotic Synergism Test (AZDAST). Interpretation of DD and MIC results followed CLSI guidelines.
次要结局
未报告次要终点
研究者
Hasnaa Osama
Beni-Suef University
Beni-Suef University