Asymptomatic Congenital CMV Treatment
Public ClinicalTrials.gov record NCT03301415. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, Single Stage, Single-Arm Investigation of Oral Valganciclovir Therapy in Infants With Asymptomatic Congenital Cytomegalovirus Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03301415
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 7 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Day to 30 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 20, 2019
- Primary completion
- Nov 4, 2020
- Completion
- Nov 4, 2020
- Last update posted
- Jan 25, 2023
2019 – 2020
United States locations
- U.S. sites
- 9
- U.S. states
- 9
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama - Children's of Alabama - Clinical Virology | Birmingham | Alabama | 35233-1711 | — |
| Arkansas Children's Hospital - Infectious Diseases | Little Rock | Arkansas | 72202 | — |
| University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases | Louisville | Kentucky | 40202 | — |
| University of Mississippi - Children's Infectious Diseases | Jackson | Mississippi | 39216-4505 | — |
| Washington University School of Medicine in St. Louis - Center for Clinical Studies | St Louis | Missouri | 63110-1010 | — |
| Carolinas Medical Center - Pediatrics - Infectious Diseases | Charlotte | North Carolina | 28203-5812 | — |
| Nationwide Children's Hospital - Neonatology - Center for Perinatal Research | Columbus | Ohio | 43205-2664 | — |
| Children's Hospital of Pittsburgh of UPMC - Pediatric Infectious Diseases | Pittsburgh | Pennsylvania | 15224-1529 | — |
| Texas Medical Center - Texas Children's Hospital | Houston | Texas | 77030-2303 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03301415, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 25, 2023 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03301415 live on ClinicalTrials.gov.