In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir (CYMEVAL2)
Drug: Valacyclovir arrow
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir : Prospective Multicenter Nonrandomized Trial|
- pregnancies with unfavourable exit [ Time Frame: 24 hours ] [ Designated as safety issue: No ]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) at 24 hours
- the viral load [ Time Frame: 1 month ] [ Designated as safety issue: No ]the viral load in the blood of the cord of the newborns infected in utero by CMV the compliance at one month the criteria of tolerance
|Study Start Date:||July 2011|
|Study Completion Date:||July 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Valacyclovir arrow
Experimental : Valacyclovir arrow 500mg give Valacyclovir arrow to all participants (open phase)
Drug: Valacyclovir arrow
dosage form:500mg, dosage:8g/day, frequency: 4 a day duration: 23 weeks maximum
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651585
|Hospital Necker Enfants Malades|
|Paris, France, 75015|
|Principal Investigator:||VILLE YVES, MD||Hospital Necker Enfants Malades, Paris France|