Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir
Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Randomized Against Valaciclovir (Step 2)
Assistance Publique - Hôpitaux de Paris
46 participants
Oct 20, 2023
INTERVENTIONAL
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
Inclusion Criteria6
- 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
Exclusion Criteria11
- 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
- Liver insufficiency (Child Pugh grade C), AST, ALT 5 x ULN, bilirubin 2 x ULN.
- Woman with known allergy to Letermovir or Valaciclovir
- Contraindication for the administration of Letermovir and Valaciclovir listed in the SmPC of Prevymis® and Zelitrex®
- Women with hypersensitivity to aciclovir
- Concomitant administration of St John's wort
- Woman treated by pimozide, ergot alkaloids, dabigatran, atorvastatin, simvastatin, rosuvastatin, pitavastatin or cyclosporin.
- Woman with hereditary intolerance to galactose, with lactose lapp deficiency, glucose or galactose malabsorption syndrome
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Interventions
Maternal daily administration of 240 milligrams of letermovir (1x240 mg-tablets) up-until delivery or TOP Placebo of Valaciclovir ; daily administration of 8 grams of valaciclovir (2 g (4 x500 mg-tablets) every 6 hours) up-until delivery or TOP
Maternal daily administration of 8 grams of valaciclovir (2 g (4 x500 mg-tablets) every 6 hours) up-until delivery or TOP Placebo of letermovir : (1x240 mg-tablets) up-until delivery or TOP
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05446571