A Phase IIIb, open label trial, to assess the safety, tolerability and efficacy of dihydroartemisinin/piperaquine (EurartesimÂ®) in Indian children and adolescent patients with acute uncomplicated Plasmodium falciparum malaria

Medicines for Malaria Venture0 个研究点目标入组 100 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•Male and Female paediatric patients aged from 6 months to less than 18 years
•Ability to swallow oral tablets as whole or crushed tablets
•Body weight more than and equal to 5 kg and less 100 kg
•Acute uncomplicated malaria, with microscopically confirmed mono-infection by P. falciparum parasitaemia comprised between 80 and less than 100000 parasites per micro liter of blood
•History of fever anytime during the preceding 24 hours or presence of fever axillary temperature more than 37.5 degree centigrate
•Ability of parents or legally acceptable representative to understand the nature of the trial and providing signed informed consent. A child assent should also be obtained when the child is 7 years and older
•Stable residence in the study area during the two months after recruitment and willingness to comply with the study protocol and the study visit schedule

•Antimalarial treatment with amodiaquine chloroquine quinine or lumefantrine within the previous 6 weeks with piperaquine or mefloquine or sulphadoxine pyrimethamine within the previous 3 months and with halofantrine or other artemisinin based compounds within the 30 days prior to screening
•Any other antimalarial treatment or antibiotics with antimalarial activity including cotrimoxazol and any herbal products within the 7 days prior to screening
•Children below five years presenting severe malnutrition defined as weight for height less than 70 percent of the median NCHS WHO reference
•Severe vomiting or dehydration
•Presence of jaundice
•Presence of intercurrent illness or any condition which in the Investigators judgement would place the patient at undue risk or interfere with the study results
•Known hypersensitivity to the artemisinin based therapy or piperaquine
•Clinical and or laboratory features of severe malaria according to WHO criteria
•Known severe renal impairment or liver insufficiency
•Moderate and severe anaemia Hb less 7 g per dL
•Pregnant or lactating females
•Female patients of child-bearing potential must be neither pregnant as demonstrated by a negative pregnancy test nor lactating and must be willing to take measures to not become pregnant during the study period
•Participation in any investigational drug study during the 30 days prior to screening or previously enrolled in the present trial

发起方

Medicines for Malaria Venture