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Congenital Cytomegalovirus: Efficacy of Antiviral Treatment (CONCERT 2)

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ClinicalTrials.gov Identifier: NCT02005822
Recruitment Status : Unknown
Verified June 2015 by Dr. Ann C.T.M. Vossen, Leiden University.
Recruitment status was:  Recruiting
First Posted : December 9, 2013
Last Update Posted : June 18, 2015
Sponsor:
Collaborators:
Stichting Nuts Ohra
Leiden University Medical Center
Information provided by (Responsible Party):
Dr. Ann C.T.M. Vossen, Leiden University

Tracking Information
First Submitted Date  ICMJE December 4, 2013
First Posted Date  ICMJE December 9, 2013
Last Update Posted Date June 18, 2015
Study Start Date  ICMJE October 2013
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2013)
Hearing assessment [ Time Frame: Age: 20 months ]
At 20 months of age hearing will be assessed with Brainstem Evoked Response Audiometry using the Vivosonic Integrity during a home visit.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2013)
  • Child development [ Time Frame: Age: 20 months ]
    At age 20 months child development will be assessed during a home visit with the Bayley Scales of Infant Development III (official Dutch translation). Additionally, parents will fill in the Dutch Child Development Inventory.
  • Viral load [ Time Frame: Baseline, weekly during 7 weeks, and at 20 months of age ]
    Viral blood load will be monitored in the treatment group(at baseline, weekly during antiviral treatment, and one week after treatment) as well as in the control group (baseline and 7 weeks after inclusion). Viral urine load will be monitored in the treatment group and in the control group (at baseline, weekly during 7 weeks after inclusion, and at the age of 20 months).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Congenital Cytomegalovirus: Efficacy of Antiviral Treatment
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Congenital Cytomegalovirus Infection
  • Sensorineural Hearing Loss
Intervention  ICMJE Drug: Valganciclovir
Infants will be treated with valganciclovir for 6 weeks, 32 mg/kg daily dose in two doses, oral solution.
Other Names:
  • Valcyte
  • Valganciclovirhydrochloride
Study Arms  ICMJE
  • Experimental: Valganciclovir
    Valganciclovir 32 mg/kg per day in two doses (16 mg/kg per dose) during 6 weeks in an oral solution.
    Intervention: Drug: Valganciclovir
  • No Intervention: Control

    Refusal control group:

    Infants in the control group receive no antiviral therapy. Counseling and treatment assigned by an audiological center remain unchanged.

    Historical control group:

    Infants with birth date 1-11-2011 till 1-07-2012 with sensorineural hearing loss and congenital CMV.

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 4, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 12 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02005822
Other Study ID Numbers  ICMJE CMV-MM-2
2013-003068-30 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Ann C.T.M. Vossen, Leiden University
Study Sponsor  ICMJE Dr. Ann C.T.M. Vossen
Collaborators  ICMJE
  • Stichting Nuts Ohra
  • Leiden University Medical Center
Investigators  ICMJE
Study Director: Ann CTM Vossen, Dr. Leiden University Medical Center
Principal Investigator: Anne Marie Oudesluys - Murphy, Prof. Dr. Leiden University Medical Center
PRS Account Leiden University Medical Center
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP