Efficacy study of artemether-lumefantrine for the treatment of Plasmodium falciparum (P. falciparum or Pf) and Plasmodium vivax (P. vivax or Pv) in Solomon Islands.

Ministry of Health0 个研究点目标入组 140 人开始时间: 2015年7月20日最近更新: 2020年1月13日

适应症

试验速览

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•(i)Sex: male or female
•(ii)Age: between 1 year and 65 years old
•(iii)Falciparum or vivax infection with parasitemia between 500 and 100,000 parasites/ul of blood
•(iv)History of fever during 48 hours prior to time of recruitment
•(v)Ability to swallow oral medication
•(vi)Is willing to give small amounts of blood via finger prick
•(vii)Written informed consent from the patient or parent/guardian (in the case of young children), assent from child (ages 8-17 years inclusive).
•(viii)Written informed consent and agreed to treatment follow-up for a total of 28 days
•(ix)Willingness on the part of the patient to return to the clinic for scheduled check-ups during the 28-day follow-up period

•(i)Severe/cerebral malaria or history of another serious medical disease
•(ii)Prior treatment with an artemisinin or another antimalarial drug within the previous 7 days
•(iii)Pregnancy and lactating
•(iv)Inability to communicate well with the investigator (poor mental development or evidence of psychiatric disorder)
•(v)Are likely to be absent from the household during the study period.
•(vi)Chronic infectious diseases other than malaria (e.g. tuberculosis)
•(vii)Known allergy and/or intolerance to drug(s) being tested

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