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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Pyrimethamine; Spiramycin; Sulfadiazine

Criteria

Inclusion Criteria:

• > 18 years old

• Toxoplasmosis infection acquired during the pregnancy documented by at least one negative serology in the first trimester and seroconversion with presence of specific IgG antibodies

• Gestational age > 14 weeks from last menstrual period

• Signature of informed consent

Exclusion Criteria:

• Lack of a documented negative serology during the pregnancy

• Antiparasitic therapy with spiramycin, pyrimethamine or sulfa drugs for more than 10 days after seroconversion and before randomization,

• Known allergy to any of the study drugs, serious allergic conditions or G6PD deficiency,

• Known hepatic or renal insufficiency,

• Other ongoing severe conditions in mother or fetus

• Lack of public health insurance