Susceptibility of Plasmodium falciparum from Southern Laos to artemether-lumefantrine and new chemical entities: in-vivo and in-vitro studies in the province of Attapeu, Laos

Medicines for Malaria Venture (MMV) (Switzerland)0 个研究点目标入组 110 人开始时间: 2009年6月30日最近更新: 2015年1月13日

试验速览

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•1. Male or female aged greater than 1 year
•2. Fever (axillary, 37.5ºC) on admission, or reported history of fever within the last 72 hours (3 days)
•3. Willingness to participate in particular to stay at the hospital for the first 7 days
•4. Full written informed consent (signed) provided by themselves or by attending relatives
•5. Signed pre-consent if patient was referred from a district hospital or dispensary
•6. Willing to stay under close medical supervision at the hospital for the study duration of at 7 days, and willingness to participate weekly until the 6th week (42 days follow-up)

•1. Pregnancy: all females (aged 12 - 50 years) are required to have a negative pregnancy test (urine) or are currently using an acceptable method of contraception
•2. Lactating mother
•3. Intake of anti-malarial drugs for the last 3 days (reported on admission, urine samples for confirmation)
•4. Mixed malaria infection on admission, i.e. P. falciparum and any other Plasmodium species
•5. A previous history of intolerance or hypersensitivity to the study drugs artemether-lumefantrine or to drugs with similar chemical structures, such as artemether, artemisinin or dihydroartemisinin and lumefantrine-like compounds
•6. History of significant cardiovascular, liver or renal functional abnormality or any other clinically significant illness
•7. Symptoms of severe vomiting
•8. Signs or symptoms of severe malaria (World Health Organization [WHO] 2003)
•9. Unable to follow the protocol
•10. Age of 12 months and below

发起方

Medicines for Malaria Venture (MMV) (Switzerland)