Overview

Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir

Status:
Not yet recruiting
Trial end date:
2028-06-01
Target enrollment:
Participant gender:
Summary
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 cord blood. 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.
Phase:
Phase 3
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
Letermovir
Valacyclovir