NCT01655212

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

June 18, 2015

Status Verified

June 1, 2015

Enrollment Period

1.3 years

First QC Date

July 13, 2012

Last Update Submit

June 17, 2015

Conditions

Congenital Cytomegalovirus InfectionSensorineural Hearing Loss

Keywords

CytomegalovirusCongenital infectionSensorineural hearing lossRandomized controlled trialValganciclovir

Outcome Measures

Primary Outcomes (1)

  • Hearing assessment

    At 1 year follow-up hearing will be assessed with Brainstem Evoked Response Audiometry at an audiological center.

    1 year follow-up

Secondary Outcomes (2)

  • Child development

    1 year follow-up

  • Viral load

    Baseline, weekly during 7 weeks, and at 1 year

Study Arms (2)

Valganciclovir

EXPERIMENTAL

Valganciclovir 32 mg/kg per day in two doses (16 mg/kg per dose) during 6 weeks in an oral solution.

Drug: Valganciclovir

Control

NO INTERVENTION

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

Interventions

ValganciclovirDRUG

Infants will be treated with valganciclovir for 6 weeks, 32 mg/kg daily dose in two doses, oral solution.

Also known as: Valcyte, Valganciclovirhydrochloride
Valganciclovir

Eligibility Criteria

Age3 Weeks - 12 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants with congenital CMV infection and hearing loss (≥ 20 dB, in one or both ears).
  • ≥ 37 weeks gestational age.
  • Birth weight ≥ 2500 gram.
  • Parental signed informed consent.

You may not qualify if:

  • Treatment with other antiviral agents or immunoglobulins.
  • Leucopenia \< 0,5 x 10\*9/L (blood sample tested at t=0).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department Medical Microbiology, Leiden University Medical Center

Leiden, South Holland, 2300 RC, Netherlands

Location

Related Publications (16)

  • Kimberlin DW, Lin CY, Sanchez PJ, Demmler GJ, Dankner W, Shelton M, Jacobs RF, Vaudry W, Pass RF, Kiell JM, Soong SJ, Whitley RJ; National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group. Effect of ganciclovir therapy on hearing in symptomatic congenital cytomegalovirus disease involving the central nervous system: a randomized, controlled trial. J Pediatr. 2003 Jul;143(1):16-25. doi: 10.1016/s0022-3476(03)00192-6.

    PMID: 12915819BACKGROUND

  • Amir J, Wolf DG, Levy I. Treatment of symptomatic congenital cytomegalovirus infection with intravenous ganciclovir followed by long-term oral valganciclovir. Eur J Pediatr. 2010 Sep;169(9):1061-7. doi: 10.1007/s00431-010-1176-9. Epub 2010 Mar 16.

    PMID: 20232081BACKGROUND

  • Lackner A, Acham A, Alborno T, Moser M, Engele H, Raggam RB, Halwachs-Baumann G, Kapitan M, Walch C. Effect on hearing of ganciclovir therapy for asymptomatic congenital cytomegalovirus infection: four to 10 year follow up. J Laryngol Otol. 2009 Apr;123(4):391-6. doi: 10.1017/S0022215108003162. Epub 2008 Jun 30.

    PMID: 18588736BACKGROUND

  • Oliver SE, Cloud GA, Sanchez PJ, Demmler GJ, Dankner W, Shelton M, Jacobs RF, Vaudry W, Pass RF, Soong SJ, Whitley RJ, Kimberlin DW; National Institute of Allergy, Infectious Diseases Collaborative Antiviral Study Group. Neurodevelopmental outcomes following ganciclovir therapy in symptomatic congenital cytomegalovirus infections involving the central nervous system. J Clin Virol. 2009 Dec;46 Suppl 4(Suppl 4):S22-6. doi: 10.1016/j.jcv.2009.08.012. Epub 2009 Sep 18.

    PMID: 19766534BACKGROUND

  • Michaels MG, Greenberg DP, Sabo DL, Wald ER. Treatment of children with congenital cytomegalovirus infection with ganciclovir. Pediatr Infect Dis J. 2003 Jun;22(6):504-9. doi: 10.1097/01.inf.0000069767.43169.2d.

    PMID: 12799506BACKGROUND

  • Nigro G, Scholz H, Bartmann U. Ganciclovir therapy for symptomatic congenital cytomegalovirus infection in infants: a two-regimen experience. J Pediatr. 1994 Feb;124(2):318-22. doi: 10.1016/s0022-3476(94)70327-2.

    PMID: 8301446BACKGROUND

  • Whitley RJ, Cloud G, Gruber W, Storch GA, Demmler GJ, Jacobs RF, Dankner W, Spector SA, Starr S, Pass RF, Stagno S, Britt WJ, Alford C Jr, Soong S, Zhou XJ, Sherrill L, FitzGerald JM, Sommadossi JP. Ganciclovir treatment of symptomatic congenital cytomegalovirus infection: results of a phase II study. National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group. J Infect Dis. 1997 May;175(5):1080-6. doi: 10.1086/516445.

    PMID: 9129069BACKGROUND

  • Smets K, De Coen K, Dhooge I, Standaert L, Laroche S, Mahieu L, Logghe N, Cossey V, Boudewyns A. Selecting neonates with congenital cytomegalovirus infection for ganciclovir therapy. Eur J Pediatr. 2006 Dec;165(12):885-90. doi: 10.1007/s00431-006-0192-2. Epub 2006 Jun 20.

    PMID: 16786362BACKGROUND

  • Foulon I, Naessens A, Foulon W, Casteels A, Gordts F. A 10-year prospective study of sensorineural hearing loss in children with congenital cytomegalovirus infection. J Pediatr. 2008 Jul;153(1):84-8. doi: 10.1016/j.jpeds.2007.12.049. Epub 2008 Mar 6.

    PMID: 18571542BACKGROUND

  • de Vries JJ, Korver AM, Verkerk PH, Rusman L, Claas EC, Loeber JG, Kroes AC, Vossen AC. Congenital cytomegalovirus infection in the Netherlands: birth prevalence and risk factors. J Med Virol. 2011 Oct;83(10):1777-82. doi: 10.1002/jmv.22181.

    PMID: 21837795BACKGROUND

  • Korver AM, de Vries JJ, Konings S, de Jong JW, Dekker FW, Vossen AC, Frijns JH, Oudesluys-Murphy AM; DECIBEL collaborative study group. DECIBEL study: Congenital cytomegalovirus infection in young children with permanent bilateral hearing impairment in the Netherlands. J Clin Virol. 2009 Dec;46 Suppl 4:S27-31. doi: 10.1016/j.jcv.2009.09.007.

    PMID: 19836301BACKGROUND

  • Fowler KB, McCollister FP, Dahle AJ, Boppana S, Britt WJ, Pass RF. Progressive and fluctuating sensorineural hearing loss in children with asymptomatic congenital cytomegalovirus infection. J Pediatr. 1997 Apr;130(4):624-30. doi: 10.1016/s0022-3476(97)70248-8.

    PMID: 9108862BACKGROUND

  • Lanari M, Lazzarotto T, Venturi V, Papa I, Gabrielli L, Guerra B, Landini MP, Faldella G. Neonatal cytomegalovirus blood load and risk of sequelae in symptomatic and asymptomatic congenitally infected newborns. Pediatrics. 2006 Jan;117(1):e76-83. doi: 10.1542/peds.2005-0629. Epub 2005 Dec 1.

    PMID: 16326692BACKGROUND

  • Lombardi G, Garofoli F, Stronati M. Congenital cytomegalovirus infection: treatment, sequelae and follow-up. J Matern Fetal Neonatal Med. 2010 Oct;23 Suppl 3:45-8. doi: 10.3109/14767058.2010.506753.

    PMID: 20807160BACKGROUND

  • Misono S, Sie KC, Weiss NS, Huang ML, Boeckh M, Norton SJ, Yueh B. Congenital cytomegalovirus infection in pediatric hearing loss. Arch Otolaryngol Head Neck Surg. 2011 Jan;137(1):47-53. doi: 10.1001/archoto.2010.235.

    PMID: 21242546BACKGROUND

  • Kimberlin DW, Acosta EP, Sanchez PJ, Sood S, Agrawal V, Homans J, Jacobs RF, Lang D, Romero JR, Griffin J, Cloud GA, Lakeman FD, Whitley RJ; National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group. Pharmacokinetic and pharmacodynamic assessment of oral valganciclovir in the treatment of symptomatic congenital cytomegalovirus disease. J Infect Dis. 2008 Mar 15;197(6):836-45. doi: 10.1086/528376.

    PMID: 18279073BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus InfectionsHearing Loss, Sensorineural

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GanciclovirAcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ann CT Vossen, Dr.

    Leiden University Medical Center

    STUDY DIRECTOR

  • Anne Marie Oudesluys-Murphy, Prof. Dr.

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD, Dept of Medical Microbiology

Study Record Dates

First Submitted

July 13, 2012

First Posted

August 1, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

June 18, 2015

Record last verified: 2015-06

Locations

NL(1)