EUCTR2013-003068-30-NL
Active, not recruiting
Phase 1
CONgenital Cytomegalovirus: Efficacy of antiviral treatment in a non-Randomized Trial with historical control group - CONCERT study 2.0
ConditionsCongenital cytomegalovirus infection.Sensorineural Hearingloss.MedDRA version: 18.0Level: LLTClassification code 10010420Term: Congenital CMV infectionSystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsValcyte
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- MC
- Enrollment
- 50
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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