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

NCT ID NCT06118515

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

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease

    WITHDRAWN

    Washington D.C., District of Columbia, 20010-2916, United States

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

    RECRUITING

    Birmingham, Alabama, 35233-0011, United States

  • Emory University School of Medicine

    RECRUITING

    Atlanta, Georgia, 30322-1014, United States

  • Louisiana State University Health Shreveport - Infectious Diseases

    WITHDRAWN

    Shreveport, Louisiana, 71101, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Nationwide Children's Hosp.-Neonatology-Ctr. for Perinatal Rsrch.

    WITHDRAWN

    Columbus, Ohio, 43205-2664, United States

  • SUNY Upstate Medical University Hospital - Pediatrics

    WITHDRAWN

    Syracuse, New York, 13210-2342, United States

  • University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases

    WITHDRAWN

    Louisville, Kentucky, 40202, United States

  • University of Minnesota - Pediatric Infectious Disease

    WITHDRAWN

    Minneapolis, Minnesota, 55454, United States

  • University of Texas Southwestern Medical Center - Pediatrics

    WITHDRAWN

    Dallas, Texas, 75390-9063, United States