A multicentrec trial to detect in vivo resistance of Plasmodium falciparum to artesunate in patients with uncomplicated malaria. - TRAC-India

ational Institute of Malaria ResearchICMR0 个研究点目标入组 140 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum
•Asexual P. falciparum parasitaemia: 10,000 to 100,000/uL, determined on a thin or thick blood film
•Fever defined as > 37.5Â°C temperature or a history of fever within the last 24 hours
•Written informed consent (by legally acceptable representative in case of children)
•Willingness and ability of the patients/guardians to comply with the study protocol for the duration of the study

•Signs of severe/complicated malaria
•Haematocrit < 25% or haemoglobin (Hb) < 8 g/dL at enrollment
•Acute illness other than malaria requiring treatment
•For females: pregnancy, lactating
•Patients who have received artemisinin or a derivative or an artemisinin-containing combination therapy (ACT) within the previous 7 days
•History of allergy or known contraindication to artemisinins, or to the ACT to be used at the site
•Previous splenectomy

发起方

ational Institute of Malaria ResearchICMR