PDF(Pubmed)
Abstract：
BACKGROUND: Herpes simplex virus (HSV) is frequently detected in the respiratory tract of mechanically ventilated patients and is associated with a worse outcome. The aim of this study is to determine whether antiviral therapy in HSV-positive patients improves outcome.
METHODS: Prospective, multicentre, open-label, randomised, controlled trial in parallel-group design. Adult, mechanically ventilated patients with pneumonia and HSV type 1 detected in bronchoalveolar lavage (≥105 copies/mL) are eligible for participation and will be randomly allocated (1:1) to receive acyclovir (10 mg/kg body weight every 8 hours) for 10 days (or until discharge from the intensive care unit if earlier) or no intervention (control group). The primary outcome is mortality measured at day 30 after randomisation (primary endpoint) and will be analysed with Cox mixed-effects model. Secondary endpoints include ventilator-free and vasopressor-free days up to day 30. A total of 710 patients will be included in the trial.
BACKGROUND: The trial was approved by the responsible ethics committee and by Germany\'s Federal Institute for Drugs and Medical Devices. The clinical trial application was submitted under the new Clinical Trials Regulation through CTIS (The Clinical Trials Information System). In this process, only one ethics committee, whose name is unknown to the applicant, and Germany\'s Federal Institute for Drugs and Medical Devices are involved throughout the entire approval process. Results will be published in a journal indexed in MEDLINE and CTIS. With publication, de-identified, individual participant data will be made available to researchers.
BACKGROUND: NCT06134492.
METHODS: Prospective, multicentre, open-label, randomised, controlled trial in parallel-group design. Adult, mechanically ventilated patients with pneumonia and HSV type 1 detected in bronchoalveolar lavage (≥105 copies/mL) are eligible for participation and will be randomly allocated (1:1) to receive acyclovir (10 mg/kg body weight every 8 hours) for 10 days (or until discharge from the intensive care unit if earlier) or no intervention (control group). The primary outcome is mortality measured at day 30 after randomisation (primary endpoint) and will be analysed with Cox mixed-effects model. Secondary endpoints include ventilator-free and vasopressor-free days up to day 30. A total of 710 patients will be included in the trial.
BACKGROUND: The trial was approved by the responsible ethics committee and by Germany\'s Federal Institute for Drugs and Medical Devices. The clinical trial application was submitted under the new Clinical Trials Regulation through CTIS (The Clinical Trials Information System). In this process, only one ethics committee, whose name is unknown to the applicant, and Germany\'s Federal Institute for Drugs and Medical Devices are involved throughout the entire approval process. Results will be published in a journal indexed in MEDLINE and CTIS. With publication, de-identified, individual participant data will be made available to researchers.
BACKGROUND: NCT06134492.
摘要：
背景：在机械通气患者的呼吸道中经常检测到单纯疱疹病毒（HSV），并且与不良预后相关。这项研究的目的是确定是否在HSV阳性患者抗病毒治疗改善结果。
方法：前瞻性，多中心,开放标签，随机化，平行组设计的对照试验。成人,在支气管肺泡灌洗中检测到的肺炎和HSV1型机械通气患者(≥105拷贝/mL)符合参与资格,并将被随机分配(1:1)接受阿昔洛韦(每8小时10mg/kg体重)治疗10天(或如果较早从重症监护病房出院)或不进行干预(对照组).主要结果是在随机化后第30天测量的死亡率（主要终点），并将使用Cox混合效应模型进行分析。次要终点包括直到第30天的无呼吸机和无血管加压药的天数。共有710名患者将被纳入试验。
背景：该试验由负责的伦理委员会和德国联邦药品和医疗器械研究所批准。临床试验申请是根据新的临床试验条例通过CTIS（临床试验信息系统）提交的。在这个过程中,只有一个道德委员会,申请人不知道其名字，和德国联邦药品和医疗器械研究所参与整个审批过程。结果将发表在MEDLINE和CTIS索引的期刊上。随着出版物，去识别，个体参与者数据将提供给研究人员。
背景：NCT06134492。
方法：前瞻性，多中心,开放标签，随机化，平行组设计的对照试验。成人,在支气管肺泡灌洗中检测到的肺炎和HSV1型机械通气患者(≥105拷贝/mL)符合参与资格,并将被随机分配(1:1)接受阿昔洛韦(每8小时10mg/kg体重)治疗10天(或如果较早从重症监护病房出院)或不进行干预(对照组).主要结果是在随机化后第30天测量的死亡率（主要终点），并将使用Cox混合效应模型进行分析。次要终点包括直到第30天的无呼吸机和无血管加压药的天数。共有710名患者将被纳入试验。
背景：该试验由负责的伦理委员会和德国联邦药品和医疗器械研究所批准。临床试验申请是根据新的临床试验条例通过CTIS（临床试验信息系统）提交的。在这个过程中,只有一个道德委员会,申请人不知道其名字，和德国联邦药品和医疗器械研究所参与整个审批过程。结果将发表在MEDLINE和CTIS索引的期刊上。随着出版物，去识别，个体参与者数据将提供给研究人员。
背景：NCT06134492。
