Could a new drug help babies with a common but dangerous birth infection?

NCT ID NCT06118515

Completed Disease control Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 4 times

Summary

This early-phase study tests an oral antiviral drug called letermovir in 12 infants born with symptomatic congenital cytomegalovirus (CMV) infection. The goal is to find the right dose and see if it safely lowers the amount of virus in the body. Babies also receive standard treatment with valganciclovir. The study will monitor drug levels, side effects, and viral rebound after stopping letermovir.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Letermovir (an antiviral drug)
What this could lead to: If it works, this could point toward a new treatment option for infants with congenital CMV, potentially improving hearing and development outcomes.
What could go wrong: This is a very early Phase 1 trial with only 12 infants, so safety and proper dosing are still unknown. The drug may not effectively control the virus or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

cytomegalovirus infection fetal cytomegalovirus syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CONGENITAL CYTOMEGALOVIRUS INFECTION

Contacts and locations

Locations

Children's of Alabama Child Health Research Unit (CHRU)

Birmingham, Alabama, 35233-0011, United States
Emory University School of Medicine

Atlanta, Georgia, 30322-1014, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

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