Impact of a Strategy Based on the PCR Testing System on Appropriate and Targeted Antimicrobial Treatment in Immunocompromised Patients With Suspected Ventilator-associated Pneumonia or Hospital-acquired Pneumonia Requiring Mechanical Ventilation : a Randomized Controlled Unblinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Increase in percentage of patients with targeted antibiotics
研究概览
简要总结
RESPIRE is a randomized, unblinded, controlled study to measure the impact of a strategy based on a PCR test on the adjustment of antimicrobial therapy in immunocompromised patients suspected with ventilator-associated or hospital-acquired pneumonia (VAP/HAP) requiring mechanical ventilation (MV) in Intensive Care Unit (ICU). The gold-standard microbiological diagnostic method for pneumonia in the ICU is based on culture identification and antimicrobial susceptibility testing. Results are obtained in several days after the initiation of empiric antimicrobial therapy, exposing patients to a potential inappropriate broad-spectrum antimicrobial treatment. We aim to measure the impact of a PCR-based strategy to improve the percentage of patients with VAP or HAP receiving targeted antimicrobial therapy 24 hours after diagnosis compared to standard care
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult immunocompromised patients hospitalized in ICU with suspected VAP or HAP requiring MV
排除标准
- •No immunodeficiency Moribund patients (SAPS II > 90) Pregnant women Refuse to participate to the study
研究组 & 干预措施
PCR group
干预措施: PCR based strategy (Other)
Control group
干预措施: Standard care (Other)
结局指标
主要结局
Increase in percentage of patients with targeted antibiotics
时间窗: 24 hours after the initiation of empiric antimicrobial therapy
To determine the impact of a PCR-based strategy on the increase in percentage of patients with targeted antibiotics regimen 24 hours after starting empiric antimicrobial therapy in the experimental group compared to standard care
次要结局
- 28 days mortality(28 days after the initiation of empiric antimicrobial therapy)
- Mechanical ventilation free days(28 days after the initiation of empiric antimicrobial therapy)
- Percentage of patients receiving appropriate anticrobial treatment(24 hours after the initiation of empiric antimicrobial therapy)
- ICU Length of stay(Until 28 days after the initiation of empiric antimicrobial therapy)
- Incidence of ICU-acquired infections and colonization involving multidrug resistant bacteria(28 days after the initiation of empiric antimicrobial therapy)