In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Acyclovir; Valacyclovir

Criteria

Inclusion criteria :

• Age ≥ 18 years,

• Fœtal Infection with CMV authenticated by the positivity of the research of the viral genome by PCR in the amniotic liquid,

• Echographic Assessment revealing at least one cerebral extra anomaly being able to be in connection with the infection with CMV,

• And/or one isolated cerebral anomaly :

• Ventriculomégalie measured with the ventricular crossroads < 15mm

• Signs of lenticulo-striated vasculopathy

• Intraparenchymateuses calcifications

• Intra-ventricular adherences

• And/or biological signs of generilazed infection to CMV :

• fetal viremia > 3000 copies/ml

• platelet < 100 000/cc

• Absence of request for termination of pregnancy from the start,

• Acceptance of a strict follow-up by a Multi-field Center of Prenatal diagnosis and of an optimal observance of the founded treatment,

• Collection of the written assent to take part in the test.

• Affiliation with a mode of social security or equivalent.

Exclusion criteria :

• Not affiliation with a mode of social security (profit or having right)

• Patient of less than 18 years,

• Patient presenting another pathology obstetrical or medical (in particular hepatic or renal) preexistent to tracking or contra-indicating the use of valacyclovir,

• Patientes whose fœtus does not present any echographic sign being able to be in connection with the infection with CMV,

• Patientes whose fœtus presents at least one cerebral echographic anomaly :

Ventriculomégalie measured with the ventricular crossroads ≥ 15mm Hyperechogenicity periventriculaire Hydrocephaly Microcephaly Increase cuts large retro-cérébelleuse cistern Hypoplasy vermienne Porencephaly Lissencephaly Cysts périventriculaires Hypoplasy of the callous body

• Patient under any other active antiviral treatment against CMV,

• Patient taking part in another therapeutic test,

• Patient refusing to sign the enlightened assent,

• Patient formulating a request for medical interruption of pregnancy before inclusion.