Eurartesim pregnancy registry

Background

Eurartesim™ (Dihydroartemisinin/Piperaquin) a novel ACT (Artemisinin-based Combination Therapy) has been licensed by the EMA (European Medicines Agency) in November 2011. Eurartesim is licensed for the treatment of uncomplicated Plasmodium falciparum malaria in patients above 6 months and a body weight over 5kg. Due to the lack of data Eurartesim™ is currently not recommended for the treatment of malaria during pregnancy. To monitor the safety of newly introduced drugs in Europe the EMA (European Medicines Agency) demands the implementation of post-marketing pregancy & safety registries. To implement a European multi-centre pregnancy registry for women unintentionally exposed to Eurartesim™ during pregancy SigmaTau commissioned TropNet.

EMA registry requests

Pregnancy: A European multi-centre pregnancy registry for patients exposed to Eurartesim™ for the treatment of malaria whilst pregnant.
Purpose: To evaluate the effect of fetal exposure to Eurartesim™ on birth defects and infant development from birth through to 12 months of age

Study design

A European multi-centre pregnancy registry for patients exposed to Eurartesim™ whilst pregnant.

Study objectives

• The primary objective of this study is to assess the live birth incidence of minor and major congenital birth defects following exposure to Eurartesim™ whilst pregnant or in the one month (30 days) prior to conception.
• The secondary objective of this study is to assess both maternal and fetal outcome following exposure to Eurartesim™ whilst pregnant or in the one month (30days) prior to conception.

Time frame

Recruitment period: Sept./Oct. 2012 – 2017

Follow-up period: 2018 – 2019

Close out period: 2019