Cytomegalovirus (CMV)Infection Clinical Trial
Official title:
In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir : Prospective Multicenter Nonrandomized Trial
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment