Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial (CONCERT)
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First Received Date ICMJE | July 13, 2012 | ||||||||
Last Updated Date | July 30, 2012 | ||||||||
Start Date ICMJE | June 2012 | ||||||||
Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Hearing assessment [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ] At 1 year follow-up hearing will be assessed with Brainstem Evoked Response Audiometry at an audiological center. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01655212 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial | ||||||||
Official Title ICMJE | Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial | ||||||||
Brief Summary | The objective of the trial is to investigate whether early treatment with oral valganciclovir of infants with both congenital cytomegalovirus infection and sensorineural hearing loss can prevent progression of hearing loss. |
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Detailed Description | In the Netherlands all neonates are routinely screened for hearing during the first weeks after birth with the Otoacoustic Emissions (OAE) procedure. After the second refer an Automated Auditory Brainstem Response (AABR) is performed. The parents of all newborns, born at ≥ 37 weeks gestational age, that fail this AABR in the Netherlands (about 550 yearly) will be asked for consent for CMV-testing on the dried blood spots. Newborns diagnosed with congenital CMV and with confirmed SNHL (≥ 20 dB) are eligible for inclusion. After informed consent infants will be randomized before the age of 13 weeks to a treatment group (6 weeks valganciclovir 32 mg/kg daily dose; oral solution) or control group (no antiviral treatment). Infants will be monitored for leucopenia and liver- and kidney function. Inclusion will continue for at least 1.5 years, or until 25 infants in each treatment arm have been randomized. At 1 year follow-up hearing and child development are assessed. Hearing will be assessed with Brainstem Evoked Response Audiometry at an audiological center. Child development will be assessed during a home visit with the Bayley Scales of Infant Development III and parents will fill in the Dutch Child Development Inventory (NCDI) which will give more detailed information on communicative development of their child. Viral loads in blood and urine will be monitored during antiviral treatment as well as twice in the control group. This study will provide information on the percentage of infants with a congenital CMV infection who fail the neonatal hearing screening . The RCT will show whether early treatment of congenital CMV infected children with hearing impairment prevents deterioration of hearing loss and to what extent. The outcome may lead to implementation of congenital CMV testing in the neonatal hearing screening program or possibly into the newborn blood screening. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Valganciclovir
Infants will be treated with valganciclovir for 6 weeks, 32 mg/kg daily dose in two doses, oral solution.
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Study Arm (s) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 50 | ||||||||
Estimated Completion Date | June 2015 | ||||||||
Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | up to 12 Weeks | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Netherlands | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01655212 | ||||||||
Other Study ID Numbers ICMJE | CMV-MM-1, 2011-005378-44 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | Dr. Ann C.T.M. Vossen, Leiden University | ||||||||
Study Sponsor ICMJE | Dr. Ann C.T.M. Vossen | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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Information Provided By | Leiden University Medical Center | ||||||||
Verification Date | July 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |