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临床试验/EUCTR2011-005378-44-NL
EUCTR2011-005378-44-NL进行中(未招募)不适用

CONgenital Cmv: Efficacy of antiviral treatment in a Randomized controlled Trial - CONCERT

MC0 个研究点开始时间: 2012年4月17日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
MC

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

性别
All

入选标准

  • Infants with congenital CMV infection, and hearing loss (=20 dB, in one or both ears).
  • Age at time of inclusion is < 12 weeks after birth.
  • >37 weeks gestational age.
  • Birth weight >2500 gram.
  • Parental signed informed consent.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 50
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Indications for symptomatic congenital CMV infection based on diagnostics carried out prior to the inclusion of the child in the trial.
  • In case during the house visit the presence of a symptomatic CMV infection is doubted, inclusion will be discussed. Depending on the medical history taking, physical examination and laboratory tests inclusion will be decided upon.
  • Treatment with other antiviral agents or immunoglobulins.
  • Leucopenia < 0,5 x 10*9/L (blood sample tested at t=0).

研究者

发起方
MC

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