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Study identifier: NCT05446571 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir

Condition: Pregnant Women · CMV Infected Fetuses  ·  Sponsor: Assistance Publique - Hôpitaux de Paris

PhasePhase 3
Planned participants46
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

The investigators' hypothesis is that maternal treatment with Letermovir will inhibit fetal CMV replication better than Valaciclovir in infected fetuses and lead to a higher proportion of negative CMV PCR at birth in neonatal blood collected in the first day of life or in cord blood in case of termination of pregnancy (TOP). The main objective is to demonstrate that Letermovir administered to women carrying a CMV infected fetus following a maternal infection of the first trimester increases the proportion of neonates with a negative CMV PCR in neonatal blood collected in the first day of life or in cord blood in case of termination of pregnancy (TOP) compared to Valaciclovir. In each group , the proportion of asymptomatic neonates and the number and type of long-term sequelae at 2 years will also be assessed and compared.

This description comes directly from the study's public registry record.

Talk to the study team

Yves VILLE, MD, PhD  ·  +33 1 71 19 63 32  ·  ville.yves@gmail.com

Aminata TRAORE  ·  +33 1 48 19 27 34  ·  aminata.traore6@aphp.fr

Always discuss trial participation with your own doctor first.

Locations (1)

Hopital Necker - Enfants maladesParis, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT05446571