In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Study ID
- NCT01651585
- Phase
- PHASE4
- Status
- Completed
Conditions
- Cytomegalovirus (CMV)Infection
- Foetuses Infection
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Valacyclovir arrow — DRUGdosage form:500mg, dosage:8g/day, frequency: 4 a day duration: 23 weeks maximum
Study Details
The infection with cytomegalovirus (CMV) is the first cause of congenital neurological handicap of infectious origin. It is probable that the néonatale viral load is correlated with becoming of infected new-born babies. Among the active antiviral treatments against CMV, valacyclovir is the only whose fœtal and maternal tolerance was evaluated during the pregnancy. Its harmlessness and its aptitude to decrease the CMV viral load justify to evaluate it in a study. Decrease the fœtal viral load could make possible to decrease symptomatology néonatale in a group of infected fœtuses.
Key Dates
- Start date
- Jul 31, 2011
- Status verified
- Aug 2025
- Primary completion
- May 31, 2015
- Completion
- Jul 31, 2015
Study Design
- Enrollment
- 41 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Valacyclovir arrowExperimental : Valacyclovir arrow 500mg give Valacyclovir arrow to all participants (open phase)
Primary Outcome Measure
pregnancies with unfavourable exit [ Time Frame: 24 hours ]