Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
Qualifiers
Pregnant woman ≥ 18 years old,
CMV infection in the 1st trimester
with an infected fetus at 15 -28 weeks (positive CMV PCR in the amniotic fluid) With a fetus presenting without any severe cerebral ultrasound feature (ventriculomegaly ≥15 mm, hydrocephalus, periventricular hyperechogenicity, microcephaly<-3SD, vermian hypoplasia, porencephaly, lissencephaly, corpus callosum dysgenesis, cystic leukomalacia)
affiliation to a social security regime//health insurance
Disqualifiers
Participation to another interventional drug trial (category 1)
Subject protected by law under guardianship or curatorship
Maternal CMV infection after 15 weeks'
Creatinine clearance <50 ml/mn/1,73m²
Trial design
Treatments tested in this trial
- Letermovir
- Valacyclovir
Treatment groups
46 Participants
are divided into 2 treatment groupsSponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator
Source ClinicalTrials.gov