In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir

• Status: Terminated
• Trial end date: 2011-06-01
• 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 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.

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

Details

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

Criteria

Inclusion Criteria:

• Age ≥ 18 years,

• Fetal 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,

• 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:

• No 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,

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

• Patients whose fetus presents at least one cerebral echographic anomaly:IntraparenchymalVentriculomegaly measured with the ventricular crossroads ≥ 12mm

• Hyperechogenicity periventricular

• Hydrocephaly

• Intra-ventricular adherence

• Microcephaly

• Increase cuts large retro-cerebellar cistern

• Hypoplasia vermis

• Intraparenchymal calcifications

• Porencephaly

• Lissencephaly

• Cysts periventricular

• Hypoplasia of the callous body

• Signs of LENTICULO-striated vasculopathy

• 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