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

Congenital Toxoplasmosis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Congenital Toxoplasmosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Pyrimethamine/SulfadiazinePyrimethamine + sulfadiazine group : Pyrimethamine 50 mg once daily orally and sulfadiazine 1g tid. orally, with supplemental folinic acid 50 mg once a week. Follow-up includes clinical and biological tolerance, according to usual recommendations. Monthly fetal ultrasound is performed. Prenatal diagnosis with amniocentesis is offered after 18 weeks gestation, usually 4 weeks after the maternal infection. Treatment is be stopped or changed in case of toxicity. If prenatal diagnosis shows fetal infection with T. gondii, management is to be determined by the clinicians with the patient. If the prenatal diagnosis is negative the treatment can be stopped in order to reduce the risk of intolerance, providing that the mother receives at least 4 weeks of therapy.

Drug:SpiramycineSpiramycin group : spiramycin 1g tid orally Follow-up includes clinical and biological tolerance, according to usual recommendations. Monthly fetal ultrasound is performed. Prenatal diagnosis with amniocentesis is offered after 18 weeks gestation, usually 4 weeks after the maternal infection. Treatment is be stopped or changed in case of toxicity. If prenatal diagnosis shows fetal infection with T. gondii, management is to be determined by the clinicians with the patient. If the prenatal diagnosis is negative the treatment is continued according to usual procedures

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Pyrimethamine/SulfadiazineWomen who are enrolled and randomised in Pyrimethamine + sulfadiazine group : Pyrimethamine 50 mg once daily orally and sulfadiazine 1g tid. orally, with supplemental folinic acid 50 mg once a week.

SpiramycineSpiramycin group : spiramycin 1g tid orally

Study Status

Completed

Start Date: November 2010

Completed Date: April 2016

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Rate of mother-to-child transmission

Secondary Outcome: Secondary Outcome Measure

Study sponsors, principal investigator, and references

Principal Investigator: Laurent Mandelbrot, MD

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01189448

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