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Prenatal Therapy With Pyrimethamine + Sulfadiazine vs Spiramycin to Reduce Placental Transmission of Toxoplasmosis: A Multicenter, Randomized Trial

Prenatal Therapy With Pyrimethamine + Sulfadiazine vs Spiramycin to Reduce Placental Transmission of Toxoplasmosis: A Multicenter, Randomized Trial

Laurent Mandelbrot, François Kieffer, Rémi Sitta, Hélène Laurichesse-Delmas, Norbert Winer, Louis Mesnard, Alain Berrebi, Gwenaëlle Le Bouar, Jean-Paul Bory, Anne-Gaëlle Cordier, Yves Ville, Franck Perrotin, etc.

Am J Obstet Gynecol. 2018 Oct;219(4):386.e1-386.e9.

PMID: 29870736

Abstract:

Background:
The efficacy of prophylaxis to prevent prenatal toxoplasmosis transmission is controversial, without any previous randomized clinical trial. In France, spiramycin is usually prescribed for maternal seroconversions. A more potent pyrimethamine + sulfadiazine regimen is used to treat congenital toxoplasmosis and is offered in some countries as prophylaxis.
Objective:
We sought to compare the efficacy and tolerance of pyrimethamine + sulfadiazine vs spiramycin to reduce placental transmission.
Study design:
This was a randomized, open-label trial in 36 French centers, comparing pyrimethamine (50 mg qd) + sulfadiazine (1 g tid) with folinic acid vs spiramycin (1 g tid) following toxoplasmosis seroconversion.
Results:
In all, 143 women were randomized from November 2010 through January 2014. An amniocentesis was later performed in 131 cases, with a positive Toxoplasma gondii polymerase chain reaction in 7/67 (10.4%) in the pyrimethamine + sulfadiazine group vs 13/64 (20.3%) in the spiramycin group. Cerebral ultrasound anomalies appeared in 0/73 fetuses in the pyrimethamine + sulfadiazine group, vs 6/70 in the spiramycin group (P = .01). Two of these pregnancies were terminated. Transmission rates, excluding 18 children with undefined status, were 12/65 in the pyrimethamine + sulfadiazine group (18.5%), vs 18/60 in the spiramycin group (30%, P = .147), equivalent to an odds ratio of 0.53 (95% confidence interval, 0.23-1.22) and which after adjustment tended to be stronger (P = .03 for interaction) when treatment started within 3 weeks of seroconversion (95% confidence interval, 0.00-1.63). Two women had severe rashes, both with pyrimethamine + sulfadiazine.
Conclusion:
There was a trend toward lower transmission with pyrimethamine + sulfadiazine, but it did not reach statistical significance, possibly for lack of statistical power because enrollment was discontinued. There were also no fetal cerebral toxoplasmosis lesions in the pyrimethamine + sulfadiazine group. These promising results encourage further research on chemoprophylaxis to prevent congenital toxoplasmosis.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP58140-A	Pyrimethamine		58-14-0	Price

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