Congenital Toxoplasmosis Clinical Trial
Official title:
Multicenter, Randomized Clinical Trial to Compare the Efficacy and Tolerance of Prenatal Therapy With Pyrimethamine + Sulfadiazine vs Spiramycine to Reduce Vertical Transmission of Toxoplasma Gondii Following Primary Infection in Pregnancy
Background : When a mother contracts toxoplasmosis during pregnancy, the parasite may be
transmitted from to her unborn child. This results in congenital toxoplasmosis, which may
cause damage to the eyes and nervous system of the child. To date, no method has been proved
effective to prevent this transmission. In France, spiramycin is usually prescribed to women
who have toxoplasma seroconversion in pregnancy, however its efficacy has not been
determined. The standard treatment for toxoplasmosis is the combination of the antiparasitic
drugs pyrimethamine and sulfadiazine, but this strategy has not been evaluated for the
prevention of mother-to-child transmission.
Purpose : Randomized phase 3 trial to determine whether pyrimethamine + sulfadiazine is more
effective than spiramycin to prevent congenital toxoplasmosis.
The protocol is a comparison of 2 strategies to prevent mother-to-child transmission of T.
gondii following maternal seroconversion.
Screening for toxoplasmosis is mandatory in France. Patients with confirmed seroconversion
will be eligible for the trial, after 14 weeks gestational age.
Participants will be randomly allocated to one of the treatment groups, and will receive
open-label pyrimethamine + sulfadiazine or spiramycin.
The protocol will not change the usual procedures for prenatal diagnosis, nor will it change
the management of infected fetuses and neonates.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05774496 -
Pregnancy and Congenital Toxoplasmosis
|
||
| Recruiting |
NCT03385499 -
New Diagnostic Approach for Congenital Toxoplasmosis
|
N/A | |
| Terminated |
NCT01202500 -
Assessment of Two Therapeutic Strategies in the Treatment of Children With Congenital Toxoplasmosis
|
Phase 3 |