Congenital Cytomegalovirus: Efficacy of Antiviral Treatment

• Status: Completed
• Trial end date: 2018-05-17
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the trial is to investigate whether early treatment with oral valganciclovir of infants with both congenital cytomegalovirus infection and sensorineural hearing loss can prevent progression of hearing loss.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Ann C.T.M. Vossen
• Collaborators: Leiden University Medical Center; Stichting Nuts Ohra
• Treatments: Antiviral Agents; Ganciclovir; Valganciclovir

Criteria

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 > -2 SD corrected for duration of pregnancy and ethnic origin.

• 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 > -2 SD corrected for duration of pregnancy and ethnic origin.

• Parental signed informed consent.

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.