CTIS2023-505510-26-00招募中1 期
Preemptive Treament with acyclovir in intubated and mechanically ventilated patients with Herpes simplex virus oropharyngeal reactivation and one or less organ failure (PTH2) - APHP220800
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 246
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •aged = 18 year-old, Invasive MV for 96 hours and planned to last for at least 48 hours longer, HSV reactivation in the throat (qualitative PCR positive for HSV on a throat swab), Presence of 1 or less organ failure; organ failure being defined as a corresponding-organ SOFA score of 3 or 4 (for example, renal failure will be defined as a renal SOFA score of 3 or 4), Written consent from the patient, from a close relative or from the person of trust previously appointed (or inclusion procedure in emergency situations), Under social security cover
排除标准
- •Hypersensitivity to acyclovir, to valacyclovir or to excipient, Decision of withholding/withdrawing care, Pregnant or breastfeeding (controlled by a urinary or blood pregnancy test), Patient who received an antiviral drug active against HSV (acyclovir, valacyclovir, gancyclovir, valgancyclovir, foscarvir, cidofovir) in the previous 30 days, Duration of ventilation before randomization >15 days, Neutropenia, defined by an absolute neutrophils count < 1,000/mm3, Solid organ or bone-marrow transplant, Immunosuppressive treatment (including steroids at a dose >0.5 mg/kg/day of prednisone or equivalent for >1 month), HIV infection, Moribund, defined by a SAPS II score at inclusion >75 points
研究者
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