drugset / Trial / NCT01651585
In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir
Phase 4
Completed
41 enrolled
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2011-07
- Primary completion
- 2015-05
- Completion
- 2015-07
Publications
- Results Bourgon N, Fitzgerald W, Aschard H, Magny JF, Guilleminot T, Stirnemann J, Romero R, Ville Y, Margolis L, Leruez-Ville M. Cytokine Profiling of Amniotic Fluid from Congenital Cytomegalovirus Infection. Viruses. 2022 Sep 28;14(10):2145. doi: 10.3390/v14102145.
- Results Leruez-Ville M, Ghout I, Bussieres L, Stirnemann J, Magny JF, Couderc S, Salomon LJ, Guilleminot T, Aegerter P, Benoist G, Winer N, Picone O, Jacquemard F, Ville Y. In utero treatment of congenital cytomegalovirus infection with valacyclovir in a multicenter, open-label, phase II study. Am J Obstet Gynecol. 2016 Oct;215(4):462.e1-462.e10. doi: 10.1016/j.ajog.2016.04.003. Epub 2016 Apr 13.
- Faure-Bardon V, Magny JF, Parodi M, Couderc S, Garcia P, Maillotte AM, Benard M, Pinquier D, Astruc D, Patural H, Pladys P, Parat S, Guillois B, Garenne A, Bussieres L, Guilleminot T, Stirnemann J, Ghout I, Ville Y, Leruez-Ville M. Sequelae of Congenital Cytomegalovirus Following Maternal Primary Infections Are Limited to Those Acquired in the First Trimester of Pregnancy. Clin Infect Dis. 2019 Oct 15;69(9):1526-1532. doi: 10.1093/cid/ciy1128.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Valacyclovir | Unknown | 8 g | Oral |