A cluster randomized, single-centre, controlled, parallel,12-month prospective study and additional 12-month follow-up in Africa of malaria incidence in a community setting following systematic treatment of P. Falciparum asymptomatic carriers with artemether-lumefantrine (Coartem® / Coartem® Dispersible)

ovartis Pharma AG0 个研究点目标入组 14,000 人开始时间: 2016年4月6日最近更新: 2016年4月11日

适应症

试验速览

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•Subjects who were diagnosed as Asymptomatic Carrier (AC) by Rapid Diagnostic Test (RDT).
•Subjects who were diagnosed with a Symptomatic malaria episode, RDT-confirmed (SMRC)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 14000
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 6800
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 950

•Body weight <5 kg.
•Hypersensitivity to artemether-lumefantrine or to any of the excipients of the tablets or dispersible tablets.
•Presence of severe malaria signs and symptoms
•First trimester of pregnancy.
•Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
•Taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents, certain non-sedating antihistamines.
•Known disturbances of electrolyte balance, e.g. hypokalemia or hypomagnesemia.
•Taking drugs which may be metabolized by cytochrome enzyme CYP2D6

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