drugset / Trial / NCT01189448

Prevention of Congenital Toxoplasmosis With Pyrimethamine + Sulfadiazine Versus Spiramycine During Pregnancy

NCT01189448

Phase 3 Completed 149 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2010-11
Primary completion
2014-07
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Spiramycin Small molecule 1 g Oral
Comparator Sulfadiazine Unknown 1 g Oral
Comparator pyrimethamine Small molecule 50 mg Oral
Comparator Leucovorin Small molecule 50 mg