NCT07203638Enrolling By Invitation不适用
Efficacy and Safety of Prophylactic Antibiotics in Preventing Ventilator-associated Pneumonia: A Randomized, Double Blind, Placebo-controlled Trial
Esraa Salah Mohamed Abdallah Eladl1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Ventilation associated pneumonia
研究概览
简要总结
Evaluate efficacy and safety of prophylactic antibiotics in preventing early ventilator-associated pneumonia
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •• Age > 18 years or older
- •Both sexes will be included.
- •Invasive mechanical ventilation
排除标准
- •ongoing pneumonia or gross aspiration confirmed by the presence of lung infiltrates on chest radiographs at admission before invasive ventilation
- •previous lung disease precluding accurate interpretation of chest radiographs
- •ongoing antibiotic therapy or during the week before admission
- •known chronic colonization with multidrug-resistant bacteria
- •known allergy to beta-lactam antibiotics
- •Pregnancy
研究组 & 干预措施
B.lactam
Active Comparator
Patient recieved beta lactam iv 1gm each 12h for 2 days
干预措施: Beta Lactam Antibiotics (Drug)
Control group
Placebo Comparator
patients in the control group will receive saline iv each 12h for 2 days
干预措施: Salin (Drug)
结局指标
主要结局
Ventilation associated pneumonia
时间窗: from the 2nd to the 7th day of mechanical ventilation
The primary outcome is the proportion of patients who will develop VAP (radiology, TLC, temperature, hemodynamic, sputum culture )from the 2nd to the 7th day of mechanical ventilation
次要结局
未报告次要终点
研究者
Esraa Salah Mohamed Abdallah Eladl
Assistant Lecturer of Critical Care Medicine
Benha University
研究点 (1)
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