Intermittent Preventive Treatment: efficacy and safety of sulfadoxine-pyrimethamine and sulfadoxine-pyrimethamine plus piperaquine in schoolchildren of the Democratic Republic of Congo. A Randomised Control Trial.

niversity of Antwerp0 个研究点目标入组 1,100 人开始时间: 2012年11月1日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•males and females primary school children,
•anticipated local residence for the study duration,
•signed or thumb-printed informed consent by the parents or guardians and witnessed by an impartial witness (whenever parents/guardians are illiterate)
•informed ascent for 12-year children or more

•Children of the 6th primary school year
•Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
•Known hypersensitivity or serious adverse events (AE) to study drugs.
•Clinical malaria at baseline irrespectively of the severity (World Health Organisation malaria treatment guideline 2010) (Annex III).
•Febrile conditions caused by diseases other than malaria at first visit.
•Clinical symptoms of severe anaemia
•Illness or conditions like hematologic, cardiac, renal, hepatic diseases which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency and sickle cell.
•Body weight < 14 Kg
•Children with major chronic infectious diseases.

发起方

niversity of Antwerp