Efficacy of amodiaquine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Nimba county, Liberia

Drugs for Neglected Diseases initiative (DNDi) (Switzerland)0 个研究点目标入组 300 人开始时间: 2008年10月9日最近更新: 2017年4月24日

适应症

试验速览

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•1. Age group of 6 and 59 months, either sex
•2. Weight greater than or equal to 5 kg
•3. Slide-confirmed infection with Plasmodium falciparum only (no mixed infections)
•4. Asexual parasite density between 2,000 and 200,000/µl of blood, and
•5. Measured axillary temperature greater than or equal to 37.5°C or history of fever in the last 48 hours, and
•6. High probability of respecting the follow-up visits (residence within 1 hour walking distance from the OPD, no upcoming travel plans, etc.), and
•7. Informed consent from a parent or guardian aged at least 18 years

•1. General danger signs according to the World Health Organization (WHO) definition
•2. Signs of severe/complicated malaria according to the WHO definition
•3. Severe anaemia (haemoglobin less than 5 g/dL)
•4. Known history of hypersensitivity to any of the study drugs
•5. Severe malnutrition (as defined by a weight-for-height below 70% of median and/or symmetrical oedemas involving at least the feet)
•6. Concomitant febrile illness judged as due to causes other than malaria with the potential to confound study outcome (measles, acute lower tract respiratory infection, otitis media, tonsillitis, abscesses, severe diarrhoea with dehydration, etc; mild flu shouldn't lead to exclusion)
•7. Having received already a full course of the treatment (or one of the treatments) under study in the previous 10 days

发起方

Drugs for Neglected Diseases initiative (DNDi) (Switzerland)