Clinical Trials Logo

Clinical Trial Summary

This is a phase II, open-label trial to evaluate valganciclovir as a treatment to prevent development of sensorineural hearing loss (SNHL) in infants with asymptomatic congenital cytomegalovirus (CMV) infection. The trial will be conducted in two phases - screening of newborns to identify eligible subjects, and treatment of those newborns who have confirmed CMV infection at birth but without outward manifestations of congenital CMV infection. 229 newborns with confirmed CMV infection but without baseline SNHL and who meet all inclusion/exclusion criteria will be enrolled into the treatment phase. Study duration is 5 years. Primary objective of this study is to estimate the proportion of subjects with asymptomatic congenital CMV infection who, following treatment with 4 months of oral valganciclovir, develop SNHL by 6 months of life.


Clinical Trial Description

This is a phase II, open-label trial to evaluate valganciclovir as a treatment to prevent development of sensorineural hearing loss (SNHL) in infants with asymptomatic congenital cytomegalovirus (CMV) infection. The trial will be conducted in two phases - screening of newborns to identify eligible subjects, and treatment of those newborns who have confirmed CMV infection at birth but without outward manifestations of congenital CMV infection. Approximately 48,250 newborn infants with no outward manifestations of congenital CMV infection will be screened to detect approximately 241 neonates with asymptomatic congenital CMV infection; these 241 newborns then will have audiology examinations to determine baseline hearing, with approximately 229 having normal hearing in both ears. Those 229 newborns with confirmed CMV infection but without baseline SNHL and who meet all inclusion/exclusion criteria will be enrolled into the treatment phase. Enrolled subjects will be treated for four months with oral valganciclovir (16 mg/kg/dose, administered two times per day). Audiologic assessments will be made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. Treated infants will be followed for safety throughout the first 6 months of the study (including for 2 months post-treatment). Study duration is 5 years. Primary objective of this study is to estimate the proportion of subjects with asymptomatic congenital CMV infection who, following treatment with 4 months of oral valganciclovir, develop sensorineural hearing loss (SNHL) by 6 months of life. Secondary objectives are to: 1) define the safety and tolerability of valganciclovir in enrolled subjects, 2) estimate the proportion of subjects with asymptomatic congenital CMV infection who, following treatment with 4 months of oral valganciclovir, develop SNHL over the first 18 months of life. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03301415
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Terminated
Phase Phase 2
Start date August 21, 2019
Completion date November 5, 2020

See also
  Status Clinical Trial Phase
Completed NCT01923636 - Prognostic Value of Neonatal Markers for the Development of Neurosensorial Sequelae in Children Infected by Cytomegalovirus in Utero N/A
Recruiting NCT03973359 - Epidemiology and Prevention of Congenital HCMV in Immune Mothers. Congenital HCMV Infection Lombardy N/A
Completed NCT02005822 - Congenital Cytomegalovirus: Efficacy of Antiviral Treatment Phase 3
Completed NCT02139423 - Diagnosis of Congenital CMV Infection in Neonates Who Failed Newborn Hearing Screening N/A
Completed NCT02351102 - Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy Phase 2/Phase 3
Withdrawn NCT02594566 - Safety, Tolerability, and Immunogenicity of a Cytomegalovirus DNA Vaccine Phase 1
Active, not recruiting NCT05170269 - Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion) Phase 3
Not yet recruiting NCT06118515 - A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus Phase 1
Completed NCT02782988 - Assesment of Olfactory Disorders and Performance of a New Olfactory Test in Children With Congenital CMV
Completed NCT02645396 - A Cohort Study of Congenital Cytomegalovirus Infection Among Pregnant Women and Their Newborns in China
Terminated NCT01655212 - Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial Phase 3
Completed NCT02710864 - A Cross-sectional Study of Congenital Cytomegalovirus Infection in Newborns in China
Completed NCT05754879 - Diagnosis of Congenital Cytomegalovirus Infection in Newborn With Particular Risk
Completed NCT01376778 - A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV) Phase 3