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

INTERVENTION: Trade Name: Valcyte Product Name: Valganciclovir Product Code: 34730 Pharmaceutical Form: Powder for oral solution INN or Proposed INN: VALGANCICLOVIR HYDROCHLORIDE CAS Number: 175865‐59‐5 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 16‐ CONDITION: Congenital cytomegalovirus infection. Sensorineural Hearingloss. ; MedDRA version: 14.1 Level: LLT Classification code 10010420 Term: Congenital CMV infection System Organ Class: 10010331 ‐ Congenital, familial and genetic disorders Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: Investigate whether early valganciclovir treatment of children with SNHL of = 20 dB, unilateral or bilateral, and a confirmed congenital CMV infection can prevent deterioration of the hearing loss at 1 year follow‐up. Primary end point(s): The primary endpoint is the status of the sensorineural hearing loss expressed in dB, in children with congenital CMV at 1 year follow‐up. Secondary Objective: 1) Investigate whether early valganciclovir treatment of children with SNHL of = 20 dB, unilateral or bilateral, and a confirmed congenital CMV infection can prevent cognitive and motor retardation. Communicative and speech development will be extensively assessed.; 2) Investigate whether early valganciclovir treatment of children with SNHL of = 20 dB, unilateral or bilateral, and a confirmed congenital CMV infection reduces the CMV viral load in urine and blood samples 6 weeks treatment and one week and one year after completion of treatment. At 1 year follow‐up solely the urine sample will be investigated for the viral load. Timepoint(s) of evaluation of this end point: The hearing loss will be evaluated at 1 year follow‐up. SECONDARY OUTCOME: Secondary end point(s): The secondary endpoint is the development of the infants. ; The tertiary endpoint is the viral load (in dried blood spots, blood and urine) during 7 weeks after inclusion and at 1 year follow‐up. Timepoint(s) of evaluation of this end point: The development of the infants will be tested at 1 year follow‐up. ; The viral load will be determined at inclusion and weekly in urine during the first 7 weeks after inclusion (total 8 moments). For treated infants it will be determined at inclusion and weekly in blood samples (total 8 moments). For untreated infants it will be determined twice in blood (at inclusion and in week 6). At 1 year follow‐up the viral load will be determined in urine for all infants. INCLUSION CRITERIA: • 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