New hope for Moms-to-Be: safer malaria drugs tested in landmark trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ≥2 weeks and \<14 weeks (13-6/7 weeks inclusive) gestation from the last menstrual period (LMP) as assessed by echography * Microscopy confirmed P. falciparum mono or mixed infections, regardless of symptoms. * Emancipated minor and aged ≥16 years * Haemoglobin ≥ 7 g/dL * Residence within the health facility catchment area * Willingness to adhere to study requirements and to deliver the baby at the local health facility * Willingness to adhere to study requirements and to deliver the baby at the local health facility Exclusion Criteria: * Known allergy to any of the study drugs * History of known pregnancy complications or poor obstetric history, such as repeated miscarriages, stillbirths, or eclampsia * History or presence of major illnesses likely to influence pregnancy outcome * Known HIV positive * Any significant illness at the time of screening requiring hospitalisation, including severe malaria * Intent to move out of the study catchment area before delivery or planned delivery out of the catchment area * Recent (2 weeks) treatment with antimalarials or antimicrobials with antimalarial activity (chloroquine, AL, DP, PA, SPAQ, ASAQ, MQAS, azithromycin, clindamycin, tetracycline, quinolones, cotrimoxazole and SP) * Twin/multiple pregnancy detected * Non-viable pregnancy confirmed by ultrasound or doppler * Known history or evidence of clinically significant cardiovascular disorders or family history of sudden death or congenital long QT syndrome or current co administration of other drugs that might contribute to a prolonged QTc interval or cause "Torsades de Point" * Chronic medical condition requiring frequent medications (e.g., TB, suspected hepatic lesions, liver disease, sickle cell disease, diabetes, epilepsy, asthma and hypertension) * Prior randomisation in this study during the current pregnancy