Congenital Cytomegalovirus: Efficacy of Antiviral Treatment

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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