Actively Recruiting
Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-31
46
Participants Needed
1
Research Sites
301 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant woman 18 years or older
- CMV infection diagnosed in the first trimester
- Fetus infected with CMV between 15 and 28 weeks confirmed by positive CMV PCR in amniotic fluid
- Fetus shows no severe brain ultrasound features (e.g., ventriculomegaly ≥15 mm, hydrocephalus, microcephaly < -3SD)
- Affiliated with social security or health insurance
- Given consent to participate in the study
- Able and willing to follow study visits and procedures
You will not qualify if you...
- Participation in another interventional drug trial
- Under legal guardianship or curatorship
- Maternal CMV infection after 15 weeks of pregnancy
- Creatinine clearance below 50 ml/min/1.73m²
- Severe liver insufficiency (Child Pugh grade C) or elevated liver enzymes
- Known allergy to Letermovir or Valaciclovir
- Contraindications to Letermovir or Valaciclovir as listed in their product information
- Hypersensitivity to aciclovir
- Taking St John's wort
- Treatment with pimozide, ergot alkaloids, dabigatran, or certain statins
- Hereditary intolerance to galactose, lactose deficiency, or glucose/galactose malabsorption syndrome
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hopital Necker - Enfants malades
Paris, France, 75015
Actively Recruiting
Research Team
Y
Yves VILLE, MD, PhD
CONTACT
A
Aminata TRAORE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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