Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial

• Status: Terminated
• Trial end date: 2013-10-01
• 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:

• 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.

• ≥ 37 weeks gestational age.

• Birth weight ≥ 2500 gram.

• Parental signed informed consent.

Exclusion Criteria:

• 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).