In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir (CYMEVAL)
|Viral Disease Cytomegalovirus Infection||Drug: Valacyclovir (ZELITREX) Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir: Prospective Multicenter Randomized Trial Versus Placebo|
- 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 fetal infection with CMV) at 24 hours [ Time Frame: six months ]
- 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 [ Time Frame: six months ]
- the compliance at one month [ Time Frame: six months ]
- the criteria of tolerance [ Time Frame: six months ]
|Study Start Date:||September 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Drug: Valacyclovir (ZELITREX)
2g, 8g/day, 4 a day 23 weeks maximum.
Placebo Comparator: Placebo
The infection with cytomegalovirus (CMV) is the first cause of congenital neurological handicap of infectious origin. It is probable that the neonatal viral load is correlated with becoming of infected new-born babies. Among the active antiviral treatments against CMV, valacyclovir is the only whose fetal 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 against placebo. Decrease the fetal viral load could make possible to decrease symptomatology neonatal in a group of infected fetuses.
To evaluate the effect of a treatment by valacyclovir injected per bone to the mother in the cases of proven fetal 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 in the treated group, 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 fetal anomalies.
The secondary objective is a reduction in the treated group, of the CMV viral load in the blood of the cord taken at birth.
The attribution of the treatments will be carried out by drawing lot, according to a procedure in double blind as of the established diagnosis of the fetal infection. In the absence of reference treatment, a placebo will be employed in the reference group. The patients included will be thus placed in one of the 2 parallel groups. 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 82 in each group. 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 fetal 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: NCT01037712
|Hospital Necker Enfants Malades|
|Paris, France, 75015|
|Principal Investigator:||Yves VILLE, PUPH||Assistance Publique - Hôpitaux de Paris|