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临床试验/NCT02322476
NCT02322476Unknown不适用

Herpes Simplex Reactivation in Adult Critical Care Patients

Rigshospitalet, Denmark0 个研究点目标入组 140 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
140
主要终点
Incidence of HSV reactivation

研究概览

简要总结

Welcome or not Herpes Simplex virus (HSV) is an ever present guest in the intensive care unit (ICU). Several studies have documented a high frequency of HSV reactivation in critically ill patients despite that clinical impact remains unknown.

详细描述

Normally primary HSV infection is asymptomatic but can under certain circumstances cause manifestations such as encephalitis and bronchopneumonitis. Bruynseels showed that HSV was detectable in the throat of two percent of healthy volunteers and three percent of patients not admitted to the ICU, this provides a broad "recruitment-base" for either latent or lytic HSV infection in the ICU. Viral dissemination to the bloodstream is seen in neonates , immunocompromised patients, but also in patients with primary herpetic gingivostomatitis. Patients testing polymerase chain reaction (PCR) positive for herpes simplex DNA in blood, have a higher rate of systemic symptoms than those testing PCR negative for herpes simplex. Additionally it is known that HSV suppression in HIV patients has beneficial effects. PCR, now being available for more than a decade, has been shown to provide a more sensitive method for the detection of HSV than culture, but viral detection does not per se translate to viral disease thus the impact of disseminated HSV infection in ICU patients remains unclear.

The investigators would like to investigate the incidence of HSV reactivation in blood and tracheal secretions critically ill patients and its impact on clinical course.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admission to ICU
  • Expected length of stay (LOS) >72 hours
  • Intubated <24 hours prior to inclusion
  • Informed consent by patient, relative or guardian

排除标准

  • Ongoing antiviral treatment/prophylaxis
  • Expected LOS <72 hours
  • Intubation >24 hours prior to inclusion
  • Withdrawal of informed consent

结局指标

主要结局

Incidence of HSV reactivation

时间窗: Approximately 16 days

Participants will be followed for the duration of the hospital stay with sampling of blood or tracheal secretions every 4 days until end of the viral reactivation period

次要结局

  • Duration of mechanical ventilation(Approximately 16 days)
  • ICU length of stay(Approximately 16 days)
  • 30/90 day mortality(30/90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Søren Aalbæk Madsen

MD

Rigshospitalet, Denmark

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