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Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir

ConditionsPregnant WomenCMV Infected Fetuses
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Letermovir

    Drug

    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

  • Valacyclovir

    Drug

    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

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: LetermovirExperimental treatment 1 intervention
Group B: ValaciclovirActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

CMV PCR in neonatal blood collected

Negative CMV PCR (\<500 IU/ml) in neonatal blood

Time frame
in the first day of life
2

CMV PCR in neonatal blood collected

Negative CMV PCR (\<500 IU/ml) in cord blood

Time frame
At Termination of pregnancy

Secondary outcomes

1

Number of asymptomatic neonates

Time frame
in the first day of life
2

Birthweight

Time frame
at birth
3

placental weight

Time frame
at birth
4

number of long-term sequelae

Time frame
at 2 years of life

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov
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