Prenatal Treatment of Congenital Cytomegalovirus Infection with Letermovir Randomized Against Valaciclovir (step 2)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Given consent for the study

• Patient must be able and willing to comply with study visits and procedures

Locations
Other Locations
France
Hopital Necker - Enfants malades
RECRUITING
Paris
Contact Information
Primary
Yves VILLE, MD, PhD
ville.yves@gmail.com
+33 1 71 19 63 32
Backup
Aminata TRAORE
aminata.traore6@aphp.fr
+33 1 48 19 27 34
Time Frame
Start Date: 2023-10-20
Estimated Completion Date: 2029-08
Participants
Target number of participants: 46
Treatments
Experimental: Letermovir
Maternal daily administration of letermovir + placebo of valaciclovir
Active_comparator: Valaciclovir
Maternal daily administration of valaciclovir + placebo of letermovir
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov