Clinical trial NCT02606266: Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance
Official title: Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Congenital Cytomegalovirus (CMV)
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 1
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Auditory threshold in db
timeFrame: 6 months
Secondary outcomes:
measure: Canal function
timeFrame: 6 months
measure: FBC (haemoglobin and leukocyte count)
timeFrame: 6 weeks
measure: Serum valganciclovir concentrations
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debré Hospital
Study officials:
References: