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临床试验/EUCTR2016-004222-42-FR
EUCTR2016-004222-42-FR进行中(未招募)1 期

Validation of the efficiency of repurposed drugs on the basis of their cellular transcriptomic signature, antagonist to that of the influenza A infection. - FLUNEXT

Centre Hospitalier Régional Universitaire de Lille0 个研究点目标入组 264 人开始时间: 2017年9月28日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
264

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • Patients hospitalized in intensive care units, older than 18
  • - For a severe flu confirmed by positive PCR on nasopharyngeal
  • - Whose evolution is less than 96 hours,
  • - The severity of the flu is assessed by a respiratory failure
  • defined by the necessity to resort to mechanical ventilation,
  • invasive or not, or to deliver oxygen with a PaO2/FiO2<200
  • The inclusion is conditioned to the detection of Influenza A
  • viruses by rapid detection kit on nasopharyngeal swab.
  • - Written informed consent from patients or their relatives.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 264
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - No consent.
  • - Hypersensibility to Oseltamivir.
  • - Negative rapid detection kit on nasopharyngeal swab.
  • - Symptoms for more than 96 hours.
  • - Moribund patients at admission.
  • - Contraindication to the molecules evaluated.
  • - Sinusal dysfonction without device.
  • - Auriculo-ventricular heart block without device.
  • - Cardiogenic pulmonary oedema.
  • - Bradycardia<40/min.
  • - Not treated coronary insufficiency.
  • - Ventricular arythmia.
  • - Hyperthryroidism.
  • - Non controlled hypertension.
  • - Obstructive cardiomyopathy.
  • - Heart valve stenosis.
  • - Pheochromocytoma.
  • -Concomitant use of beta-blockers, antiarythmic drugs,
  • especially amiodarone.
  • - Pregnant/nursing woman
  • - No social insurance cover
  • -Patient under a regim of juridic protection

研究者

发起方
Centre Hospitalier Régional Universitaire de Lille

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