In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir — CYMEVAL  

Cytomegalovirus Infection Clinical Trial

Official title: In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir: Prospective Multicenter Randomized Trial Versus Placebo

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Cytomegalovirus Infection
• Cytomegalovirus Infections
• Infection
• Viral Disease
• Virus Diseases

• NCT number: NCT01037712
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Terminated
• Phase: Phase 4
• Start date: September 2009
• Completion date: June 2011