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Eligibility
for people ages up to 5 months
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

The overall goal of this study is to determine the clinical benefit and safety of antiviral therapy for asymptomatic congenital cytomegalovirus (cCMV) infected hearing-impaired infants. We will conduct a multi-center double-blind randomized placebo-controlled trial to determine whether hearing-impaired infants with asymptomatic cCMV have better hearing and language outcomes if they receive valganciclovir antiviral treatment. We will also determine the safety of antiviral valganciclovir therapy for asymptomatic cCMV-infected hearing impaired infants. This study will be unique in that the cohort enrolled will only include hearing-impaired infants with asymptomatic cCMV. Aim 1: Test the hypothesis that asymptomatic CMV-infected hearing impaired infants treated with antiviral valganciclovir will have better hearing and language outcomes compared with untreated CMV-infected hearing impaired infants. Aim 2: Evaluate the safety of antiviral valganciclovir therapy for asymptomatic CMV-infected hearing impaired infants. Aim 3: Evaluate the pharmacokinetics (pK) of valganciclovir using pharmacometrics modeling to develop a population pK model.

Official Title

Randomized Controlled Trial of Valganciclovir for Asymptomatic Cytomegalovirus Infected Hearing Impaired Infants: ValEAR Trial

Details

Cytomegalovirus (CMV) can be transmitted from the mother to the fetus and is a leading cause of sensorineural hearing loss (SNHL), which is a condition where the inner ear is unable to convert sound into nerve impulses to the brain. This hearing loss and its detrimental effect on language development contribute nearly $4 billion annually to the health care costs in the U.S. Unlike other types of SNHL, CMV induced hearing loss can be treated. Several clinical trials have demonstrated that antiviral therapy may prevent progressive hearing loss if administered early in life for severely affected (symptomatic CMV) infants. These promising findings have given rise to a debate regarding the best method for identifying and treating the more numerous asymptomatic CMV-infected infants.

One approach is to conduct universal newborn hearing screens, and then do CMV diagnostic testing only on the infants who fail the hearing screen. This targeted approach should identify those infants at greatest risk of developing progressive hearing loss and consequent communicative difficulties. Utah is the first state to mandate this approach whereby infants under three weeks of age who fail their newborn hearing screening undergo CMV testing. In this trial, the hearing screen targeted approach will be used to identify patients eligible for participation in a double blind placebo controlled randomized clinical trial of antiviral valganciclovir therapy. The results of this trial will inform public policy, potentially shift our current clinical practice regarding pediatric hearing loss evaluation, and potentially offer a therapeutic option to asymptomatic CMV-infected infants with SNHL.

Keywords

Cmv Congenital CMV Congenital Cmv SNHL Sensorineural Hearing Loss valganciclovir Ganciclovir

Eligibility

You can join if…

Open to people ages up to 5 months

  • Age less than 6 months at the time of randomization; AND
  • Less than or equal to 37 weeks gestational age at birth; AND
  • Positive congenital CMV by urine culture or polymerase chain reaction test(PCR), OR saliva culture or PCR followed by confirmatory urine PCR by 21 days of age, OR urine culture or PCR after 21 days of age followed by newborn dry blood spot PCR; AND
  • Failed hearing screen, with confirmed sensorineural hearing loss (SNHL) by auditory brainstem response (ABR) testing.

You CAN'T join if...

  • Imminent demise; OR
  • Lack of commitment to aggressive care; OR
  • Significant gastrointestinal disorders (e.g., eosinophilic esophagitis, ulcerative colitis); OR
  • Significant hematologic disorders (e.g., hemophilia, leukemia, sickle cell anemia);OR
  • Significant renal disorders (e.g., nephrotic syndrome); OR
  • Receiving other antiviral medications or immune globulin therapy; OR
  • Receiving other investigational drugs; OR
  • Breast feeding from a mother receiving antiviral or immunosuppressive medication; OR
  • Other known cause contributing to SNHL (e.g., meningitis, aminoglycoside ototoxicity); OR
  • Bilateral profound SNHL or auditory neuropathy spectrum disorder; OR
  • Evidence of intracranial calcification; OR
  • Evidence of hydrocephalus; OR
  • Microcephaly; OR
  • Presence of petechiae; OR
  • Intrauterine growth retardation; OR
  • Hepatitis; OR
  • Parent or guardian unable to speak English or Spanish; OR
  • Patient unable to attend follow-up hearing and developmental assessment at 12 months of age.

Locations

  • Lucile Packard Children's Hospital not yet accepting patients
    Palo Alto, California, 94304, United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Albert Park
ID
NCT03107871
Phase
Phase 3
Study Type
Interventional
Last Updated
April 1, 2017
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