Clinical Trial: Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance
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 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.
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: Auditory threshold in db [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: November 5, 2015
Date Started: October 2016
Date Completion: April 2019
Last Updated: August 12, 2016
Last Verified: August 2016
