Brief Title
Congenital Cytomegalovirus: Efficacy of Antiviral Treatment
Official Title
The Leiden CONCERT Study 2.0 Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Non-Randomized Trial With Historical Control Group
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.
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 offered treatment before the age of 13 weeks (6 weeks valganciclovir
32 mg/kg daily dose; oral solution). Parents may decide to participate in the trial in the
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 at least 40
infants have been included in the trial.
At age 20 months hearing and child development are assessed in the follow-up. Hearing will be
assessed with Brainstem Evoked Response Audiometry with the Vivosonic Integrity. Child
development will be assessed with the Bayley Scales of Infant Development III (official Dutch
translation) and parents will fill in the Dutch Child Development Inventory (NCDI) which will
give more detailed information on communicative development of their child. The hearing
assessment and developmental examination will be fulfilled during a home visit. 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 trial 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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Hearing assessment
Secondary Outcome
Child development
Condition
Congenital Cytomegalovirus Infection
Intervention
Valganciclovir
Study Arms / Comparison Groups
Valganciclovir
Description: Valganciclovir 32 mg/kg per day in two doses (16 mg/kg per dose) during 6 weeks in an oral solution.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
October 2013
Completion Date
October 2016
Primary Completion Date
October 2016
Eligibility Criteria
Inclusion Criteria Treatment group and refusal control group
- Infants with congenital CMV infection, and hearing loss (≥ 20 dB, in one or both
ears).
- Age at time of inclusion is ≤ 12 weeks after birth.
- Born at ≥ 37 weeks gestational age.
- Birth weight > -2 SD corrected for duration of pregnancy and ethnic origin.
- Parental signed informed consent.
Historical control group
- Infants with congenital CMV infection, and hearing loss (≥ 20 dB, in one or both
ears).
- Age at time of inclusion is > 13 weeks after birth.
- Born at ≥ 37 weeks gestational age.
- Birth weight > -2 SD corrected for duration of pregnancy and ethnic origin.
- Parental signed informed consent.
Exclusion Criteria Treatment group and refusal control group
- Previously noted (≤ 12 weeks after birth) symptoms possibly related to congenital CMV,
for which medical attention was requested. For example: intra uterine growth
retardation, petechiae, hepatosplenomegaly, jaundice, microcephaly, thrombocytopenia,
elevated transaminases, elevated bilirubin.
- Treatment with other antiviral agents or immunoglobulins.
- Solely applicable for treatment group: leucopenia < 0,5 x 10*9/L (blood sample tested
at t=0).
Historical control group
- Previously encountered (≤ 12 weeks after birth) symptoms possibly related to
congenital CMV, for which medical attention was requested For example: intra uterine
growth retardation, petechiae, hepatosplenomegaly, jaundice, microcephaly,
thrombocytopenia, elevated transaminases, elevated bilirubin.
- Treatment with (val)ganciclovir.
- Treatment with other antiviral agents or immunoglobulins.
Gender
All
Ages
N/A - 12 Weeks
Accepts Healthy Volunteers
No
Contacts
Ann CTM Vossen, Dr., +31 (0)71 525 5383 / 3931, [email protected]
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT02005822
Organization ID
CMV-MM-2
Secondary IDs
2013-003068-30
Responsible Party
Sponsor-Investigator
Study Sponsor
Dr. Ann C.T.M. Vossen
Collaborators
Stichting Nuts Ohra
Study Sponsor
Ann CTM Vossen, Dr., Study Director, Leiden University Medical Center
Verification Date
June 2015