Clinical trial NCT02005822 - References

Sensorineural Hearing Loss — Congenital Cytomegalovirus: Efficacy of Antiviral Treatment

Citation(s)

•   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.
•   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.
•   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.
•   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.
•   Kimberlin DW, Acosta EP, Sánchez 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.
•   Kimberlin DW, Lin CY, Sánchez 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.
•   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.
•   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.
•   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. Epub 2005 Dec 1. Erratum in: Pediatrics. 2006 Apr;117(4):1467.
•   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. Review.
•   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.
•   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.
•   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.
•   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. Epub 2006 Jun 20. Review.
•   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.

The Leiden CONCERT Study 2.0 Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Non-Randomized Trial With Historical Control Group

Details for clinical trial NCT02005822