EUCTR2013-003068-30-NL进行中（未招募）1 期
CONgenital Cytomegalovirus: Efficacy of antiviral treatment in a non-Randomized Trial with historical control group - CONCERT study 2.0
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- MC
- 入组人数
- 50
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
- •Treatment group and refusal control group
- •- 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.
- •- Born at = 37 weeks gestational age.
- •- Birth weight = 2500 gram.
- •- Parental signed informed consent.
- •Historical control group
- •- Infants with congenital CMV infection, and hearing loss (= 20 dB, in one or both ears).
- •- Age at time of inclusion is > 13 weeks after birth.
- •- Born at = 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
- •Treatment group and refusal control group
- •- Previously noted (= 12 weeks after birth) symptoms possibly related to congenital CMV, for which medical attention was requested. For example: intra uterine growth retardation, petechiae, hepatosplenomegaly, jaundice, microcephaly, thrombocytopenia, elevated transaminases, elevated bilirubin.
- •- Treatment with other antiviral agents or immunoglobulins.
- •- Solely applicable for treatment group: leucopenia < 0,5 x 10*9/L (blood sample tested at t=0).
- •Historical control group
- •- Previously encountered (= 12 weeks after birth) symptoms possibly related to congenital CMV, for which medical attention was requested For example: intra uterine growth retardation, petechiae, hepatosplenomegaly, jaundice, microcephaly, thrombocytopenia, elevated transaminases, elevated bilirubin.
- •- Treatment with (val)ganciclovir.
- •- Treatment with other antiviral agents or immunoglobulins.
研究者
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