NCT02152358已完成4 期
Efficacy of a Preemptive Treatment by Ganciclovir or by Aciclovir in ICU Patients Requiring Prolonged Mechanical Ventilation and Presenting a Viral Replication (CMV and/or HSV) - Prospective, Randomized, Double-blinded Multicenter Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 317
- 试验地点
- 1
- 主要终点
- Ventilator-free days at Day 60
研究概览
简要总结
The aim of this study is to show that a preemptive treatment by ganciclovir (for positive CMV viremia) or aciclovir (for positive HSV oro-pharyngeal PCR) is able to increase the number of ventilator-free days at Day 60.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •mechanical ventilation > 96 hrs and expected duration of mechanical ventilation of at least 2 days
- •positive blood CMV PCR (500 IU/ml) OR positive oropharyngeal HSV PCR
- •age > 18 years
- •informed consent
- •negative pregnancy test
排除标准
- •< 18 years
- •Receiving ganciclovir or aciclovir or another antiviral agent active against HSV/CMV
- •Had received antiviral agent active against HSV/CMV during the previous month
- •Hypersensitivity to aciclovir/ganciclovir
- •Pregnancy
- •Breast feeding
- •Bone marrow failure
- •Solid organ recipients
- •Bone marrow recipients
- •HIV positive patients
- •Receiving immunosuppressive agents
- •SAPS II > 75
- •Withdrawing/withholding
- •Neutropenia (< 500 mm3)
- •Thrombocytopenia (< 25 G/L)
- •ICU readmission
研究组 & 干预措施
Ganciclovir
Active Comparator
Patients with a positive CMV PCR
干预措施: Ganciclovir (Drug)
Ganciclovir placebo
Placebo Comparator
Patients with a positive CMV PCR
干预措施: Placebo (Drug)
Aciclovir
Active Comparator
Patients with a PCR positive for HSV
干预措施: Aciclovir (Drug)
Aciclovir placebo
Placebo Comparator
Patients with a positive PCR for HSV
干预措施: Placebo (Drug)
结局指标
主要结局
Ventilator-free days at Day 60
时间窗: 60 days
次要结局
- Acute renal failure related to aciclovir or its placebo(60 days)
- Incidence of ventilator-associated pneumonia(60 days)
- Duration of hospital stay(60 days)
- Day 60 mortality(60 days)
- ICU mortality(60 days)
- Duration of mechanical ventilation in survivors(60 days)
- Time to oropharyngeal negativation of HSV PCR(30 days)
- Time to blood negativation of CMV PCR(30 days)
- Incidence of herpetic bronchopneumonia(60 days)
- Incidence of active CMV infection(60 days)
- Hospital mortality(60 days)
- Duration of ICU stay(60 days)
- Incidence of bacteremia(60 days)
- SOFA score(days 3, 5, 7, 14, 21 and 28)
- Leucopenia related to ganciclovir or its placebo(60 days)
研究者
研究点 (1)
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