Prenatal therapy with pyrimethamine + sulfadiazine vs spiramycin to reduce placental transmission of toxoplasmosis: a multicenter, randomized trial

Laurent Mandelbrot; Francois Kieffer; Rémi Sitta; Hélène Laurichesse-Delmas; Norbert Winer; Louis Mesnard; Alain Berrebi; Gwenaelle Le Bouar; Jean-Paul Bory; Anne-Gaëlle Cordier; Yves Ville; Franck Perrotin; Jean-Marie Jouannic; Florence Biquard; Claude D’ercole; Véronique Houfflin-Debarge; Isabelle Villena; Rodolphe Thiebaut; Denis Pons; C. Nourrisson; Rose-Anne Lavergne; Judith Fillaux; Corinne Assouline; Florence Robert-Gangneux; Coralie L’ollivier; Florence Bretelle; Béatrice Guidicelli; Patricia Garcia; Alexandra Benachi; Christelle Vauloup-Fellous; Emmanuelle Letamendia; Marie-Elisabeth Bougnoux; Nathalie van Langendonck; Jérôme Potin; Pierre Marty; Christelle Pomares; Cynthia Trastour; Anne Sophie Deleplancque; Jean-Marc Costa; Marie-Thérèse Chève; Yves Col; Bernard Cimon; Y. Sterkers; Laurence Lachaud; Gilles Burlet; Martine Maréchaud; Estelle Perraud; Anne-Gaelle Grébille; Morgane Valentin; Sandrine Houzé; Sophie Omnès; Yvon Chitrit; Christine Boissinot; Hélène Yera; Olivia Anselem; Vassilis V. Tsatsaris; Marie-Victoire Senat; Florent Fuchs; Adela Angoulvant; Charles Muszynski; Anne Totet; Catherine Noël; Laurent Bidat; Tiphaine Barjat; Pierre Flori; Hervé Pelloux; Pierre Brenier-Pinchart; Catherine Thong-Vanh; Corinne Floch; Lionel Carbillon; Eric Lachassine; Aude Ricbourg; Luc Paris; Marc Dommergues; Thierry Rousseau; Frédéric Dalle; Marie Laure Darde; Véronique Aubard; Camille Olivier; Eric Verspyk; Loïc Favennec

doi:10.1016/j.ajog.2018.05.031

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Prenatal therapy with pyrimethamine + sulfadiazine vs spiramycin to reduce placental transmission of toxoplasmosis: a multicenter, randomized trial

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Prenatal therapy with pyrimethamine + sulfadiazine vs spiramycin to reduce placental transmission of toxoplasmosis: a multicenter, randomized trial

Laurent Mandelbrot, Francois Kieffer, Rémi Sitta, Hélène Laurichesse-Delmas, Norbert Winer, Louis Mesnard, Alain Berrebi, Gwenaelle Le Bouar, Jean-Paul Bory, Anne-Gaëlle Cordier, …

American Journal of Obstetrics and Gynecology, Vol.219(4), pp.386.e1-386.e9

10/2018

DOI: https://doi.org/10.1016/j.ajog.2018.05.031

PMID: 29870736

Résumé

spiramycin

pyrimethamine-sulfadiazine

prenatal diagnosis

pregnancy

tolerance

toxoplasmosis

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.

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Titre: Prenatal therapy with pyrimethamine + sulfadiazine vs spiramycin to reduce placental transmission of toxoplasmosis: a multicenter, randomized trial
Créateurs - sans rôle: Laurent Mandelbrot - Assistance Publique – Hôpitaux de Paris
Francois Kieffer - Assistance Publique – Hôpitaux de Paris
Rémi Sitta - Hôpital Paul-Brousse
Hélène Laurichesse-Delmas - Centre Hospitalier Universitaire de Clermont-Ferrand
Norbert Winer - PhysioPathologie des Adaptations Nutritionnelles
Louis Mesnard - Centre hospitalier universitaire d'Orléans
Alain Berrebi - Hôpital Paule de Viguier
Gwenaelle Le Bouar - Centre Hospitalier Universitaire de Rennes
Jean-Paul Bory
Anne-Gaëlle Cordier - Assistance Publique – Hôpitaux de Paris
Yves Ville - Assistance Publique – Hôpitaux de Paris
Franck Perrotin - Centre Hospitalier Universitaire de Tours
Jean-Marie Jouannic - Charmo University
Florence Biquard - Service de gynécologie-obstétrique
Claude D’ercole - Assistance Publique Hôpitaux de Marseille
Véronique Houfflin-Debarge - Centre Hospitalier Universitaire de Lille
Isabelle Villena - Centre Hospitalier Universitaire de Reims
Rodolphe Thiebaut - Université de Bordeaux
Denis Pons - Centre Hospitalier Universitaire de Rouen
C. Nourrisson - Laboratoire Microorganismes Génome et Environnement
Rose-Anne Lavergne - Centre de Physiopathologie Toulouse Purpan
Judith Fillaux - Service de Parasitologie et Mycologie [CHU Toulouse]
Corinne Assouline - Centre Hospitalier Universitaire de Toulouse
Florence Robert-Gangneux - Institut de Recherche en Santé, Environnement et Travail
Coralie L’ollivier - Assistance Publique Hôpitaux de Marseille
Florence Bretelle - Gynépole
Béatrice Guidicelli - Assistance Publique Hôpitaux de Marseille
Patricia Garcia - Assistance Publique Hôpitaux de Marseille
Alexandra Benachi - Hôpital Antoine-Béclère
Christelle Vauloup-Fellous - Hôpital Antoine-Béclère
Emmanuelle Letamendia - Division of Pediatrics and Neonatal Critical Care, FAME Department, South Paris
Marie-Elisabeth Bougnoux - Hôpital Necker-Enfants Malades
Nathalie van Langendonck - Centre Hospitalier Universitaire de Tours
Jérôme Potin - Centre Hospitalier Universitaire de Tours
Pierre Marty - Centre Méditerranéen de Médecine Moléculaire
Christelle Pomares - Anofel Cryptosporidium National Network
Cynthia Trastour - Centre Antoine Lacassagne
Anne Sophie Deleplancque - Centre Hospitalier Universitaire de Lille
Jean-Marc Costa - Laboratoire de Biologie Moléculaire
Marie-Thérèse Chève - Centre Hospitalier du Mans
Yves Col
Bernard Cimon - Interaction Hôtes Agents Pathogènes
Y. Sterkers - Maladies Infectieuses et Vecteurs: Écologie, Génétique, Évolution et Contrôle
Laurence Lachaud - Centre Hospitalier Universitaire de Montpellier
Gilles Burlet - Centre Hospitalier Universitaire de Montpellier
Martine Maréchaud - Centre Hospitalier Universitaire de Poitiers
Estelle Perraud - Centre Hospitalier Universitaire de Poitiers
Anne-Gaelle Grébille - Assistance Publique – Hôpitaux de Paris
Morgane Valentin - Hôpital Bichat-Claude-Bernard
Sandrine Houzé - Charmo University
Sophie Omnès - Hôpital Bichat-Claude-Bernard
Yvon Chitrit - Assistance Publique – Hôpitaux de Paris
Christine Boissinot - Hôpital Robert-Debré
Hélène Yera - Hôpital Cochin
Olivia Anselem - Assistance Publique – Hôpitaux de Paris
Vassilis V. Tsatsaris - Hôpital Cochin
Marie-Victoire Senat - Service de Gynécologie-Obstétrique [Bicêtre]
Florent Fuchs - Service de gynécologie-obstétrique et médecine de la reproduction
Adela Angoulvant - Anofel Cryptosporidium National Network
Charles Muszynski - Biomécanique et Bioingénierie
Anne Totet - Centre Hospitalier Universitaire Amiens-Picardie
Catherine Noël - Centre Hospitalier René-Dubos
Laurent Bidat - Centre Hospitalier René-Dubos
Tiphaine Barjat
Pierre Flori - Groupe Immunité des Muqueuses et Agents Pathogènes
Hervé Pelloux - Laboratoire de parasitologie-mycologie
Pierre Brenier-Pinchart
Catherine Thong-Vanh - Centre Hospitalier Universitaire de Grenoble
Corinne Floch - Institut Jacques Monod
Lionel Carbillon - Hôpital Jean-Verdier
Eric Lachassine - Hôpital Jean-Verdier
Aude Ricbourg - Assistance Publique Hôpitaux de Marseille
Luc Paris - Pitié-Salpêtrière Hospital
Marc Dommergues - Pitié-Salpêtrière Hospital
Thierry Rousseau - Centre Max Weber
Frédéric Dalle - Université de Bourgogne
Marie Laure Darde - Anofel Cryptosporidium National Network
Véronique Aubard - Hôpital Mère-Enfant
Camille Olivier - Assistance Publique – Hôpitaux de Paris
Eric Verspyk - Centre Hospitalier Universitaire de Rouen
Loïc Favennec - Appareil Digestif Environnement Nutrition
Détails de publication: American Journal of Obstetrics and Gynecology, Vol.219(4), pp.386.e1-386.e9
Identifiants: 99141543809311
Unité académique: Maladies Infectieuses et Vecteurs : Ecologie, Génétique, Evolution et Contrôle - MIVEGEC
Langue: English
Type de ressource: Journal article
Champs locaux: hal-01987714