Efficacy of antiviral treatment of congenital cytomegalovirus in a randomized controlled trial

• Conditions: Congenital cytomegalovirus infection.Sensorineural Hearingloss.; MedDRA version: 14.1Level: LLTClassification code 10010420Term: Congenital CMV infectionSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-005378-44-NL
• Lead Sponsor: MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-17
• Last Update Posted: 10 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified