Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance

Overview

Congenital cytomegalovirus (CMV) infection is the leading cause of non-genetic neurosensory deafness and affects 0.5 to 1% of births. Twenty to thirty per cent of children will develop deafness, some of whom will progress gradually to profound bilateral deafness. No curative treatment is currently offered for this deterioration in hearing and management involves the use of a hearing aid or cochlear implant. Many studies describe the utility of antiviral treatment on the course of the deafness. These mostly involve neonates with multi-system symptomatic forms of the infection who have been given 6 weeks of ganciclovir possibly switched to valganciclovir, which has shown benefit in stabilising auditory loss, or even improvement.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 11, 2018

Detailed Description

Congenital cytomegalovirus (CMV) infection is the leading cause of non-genetic neurosensory deafness and affects 0.5 to 1% of births. Twenty to thirty per cent of children will develop deafness, some of whom will progress gradually to profound bilateral deafness. No curative treatment is currently offered for this deterioration in hearing and management involves the use of a hearing aid or cochlear implant. Many studies describe the utility of antiviral treatment on the course of the deafness. These mostly involve neonates with multi-system symptomatic forms of the infection who have been given 6 weeks of ganciclovir possibly switched to valganciclovir, which has shown benefit in stabilising auditory loss, or even improvement.

Interventions

  • Drug: Valganciclovir
    • Oral valganciclovir (Rovalcyte 50 mg/ml, powder for oral suspension) at a dose of 16 mg/kg 2 times/day (max 900 mg/d) for 6 weeks.

Arms, Groups and Cohorts

  • Experimental: Valganciclovir
    • Oral valganciclovir (Rovalcyte 50 mg/ml, powder for oral suspension), at a dose of 16 mg/kg 2 times/day (max 900 mg/d) for 6 weeks.
  • No Intervention: Control group
    • Control group with standard care who do not receive the investigational medicinal product

Clinical Trial Outcome Measures

Primary Measures

  • Auditory threshold in db
    • Time Frame: 6 months

Secondary Measures

  • Canal function
    • Time Frame: 6 months
    • Canal function will be assessed using 3 tests : caloric reflex tests; electronystamography & HIT (Head Impulse Test)
  • FBC (haemoglobin and leukocyte count)
    • Time Frame: 6 weeks
  • Serum valganciclovir concentrations
    • Time Frame: 6 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Children ≥ 6 months old and < 12 years old – Past history of proven congenital CMV infection – Auditory threshold of between 40 and 90 dB in at least 1 ear. Exclusion Criteria:

  • Bilateral deafness > 90 dB – Contraindication to valganciclovir, particularly: Neutropenia with a known neutrophil count of <500/mm3, Hb<8g/dl or platelets< 25,000/mm3 (FBC to be confirmed before randomisation) – Past history of neutropenia on valganciclovir or allergy to the compound – Renal impairment with creatinine clearance of < 10 ml/min/1.72m2 (confirmation of renal function before randomisation) according to the Schwartz equation – Patients on other antiviral treatment – Gastrointestinal absorption problems – Patients participating in a biomedical research project on a medicinal product or similar product

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor

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