Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT05446571
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • CMV Infected Fetuses
  • Pregnant Women

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Oct 20, 2023
Status verified
Mar 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Letermovir
    Maternal daily administration of letermovir + placebo of valaciclovir
  • Active Comparator: Valaciclovir
    Maternal daily administration of valaciclovir + placebo of letermovir

Primary Outcome Measure

CMV PCR in neonatal blood collected [ Time Frame: in the first day of life ]

Central Contacts

Related Studies