NCT01651585

In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir

In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir : Prospective Multicenter Nonrandomized Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 infected fœtuses. To evaluate the effect of a treatment by valacyclovir injected per bone to the mother in the cases of proven fœtal infection with CMV (positive PCR CMV in the amniotic liquid) and presenting cerebral extra echographic signs being able to be allotted to the infection. The main objective is to observe a reduction in the number of unfavourable exits (symptomatic children at birth) and a reduction in the number of medical interruptions of pregnancy practised for fœtal anomalies. The secondary objective is a reduction of the CMV viral load in the blood of the cord taken at birth. The patients included will be treated. The observance will be evaluated. Taking into consideration our preliminary study, a difference of 20% between the 2 groups can be discounted. The number calculated of subjects to include in the test in order to guarantee a power of 80% to him is of 43. Recruitment will be carried out in a multicentric way. The necessary duration of inclusion will be 36 months The comparison of the two treatments will be carried out on the composite principal criterion according to : proportion of pregnancies with unfavourable exit (symptomatic children at birth or medical interruptions of pregnancy practised for which has appeared cerebral echographic anomalies in connection with the fœtal infection with CMV). The secondary criteria of judgement will be : the viral load in the blood of the cord of the newborns infected in utero by CMV, the compliance and the criteria of tolerance.

Conditions

• Foetuses Infection
• Cytomegalovirus (CMV)Infection

Interventions

Type	Name	Description
DRUG	Valacyclovir arrow	dosage form:500mg, dosage:8g/day, frequency: 4 a day duration: 23 weeks maximum

Timeline

• Start date: 2011-07-01
• Primary completion: 2015-05-01
• Completion: 2015-07-01
• First posted: 2012-07-27
• Last updated: 2025-09-05

Locations

1 site across 1 country: France