Congenital Cytomegalovirus (CMV)
Conditions
Brief summary
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.
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
DRUGValganciclovir
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.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Auditory threshold in db | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Canal function | 6 months | Canal function will be assessed using 3 tests : caloric reflex tests; electronystamography & HIT (Head Impulse Test) |
| FBC (haemoglobin and leukocyte count) | 6 weeks | — |
| Serum valganciclovir concentrations | 6 weeks | — |
Countries
France
Outcome results
None listed