A multi-centre randomised controlled non-inferiority trial to compare the efficacy, safety and tolerability of Triple Artemisinin-based Combination Therapies versus first-line ACTs + placebo for the treatment of uncomplicated Plasmodium falciparum malaria in Africa

niversity of Oxford0 个研究点目标入组 3,240 人开始时间: 2021年4月14日最近更新: 2023年5月29日

适应症

试验速览

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•Male or female, aged =6 months to <12 years (For Gambia, Rwanda sites only: =6 months)
•Ability to take oral medication
•Acute uncomplicated P. falciparum monoinfection
•Asexual P. falciparum parasitaemia: 1,000/µL to =10% parasitaemia, determined on a peripheral blood film (At Gambia, Rwanda sites only: For subjects =12 years – 1000/µL to 200,000/µL)
•Fever defined as = 37.5°C tympanic temperature or a history of fever within the last 24 hours
•Written informed consent by the subject or by the parent/guardian in case of children lower than the age of consent and assent if required (per local regulations)
•Willingness and ability of the subjects or parents/guardians to comply with the study protocol for the duration of the study

•?Signs of severe malaria (adapted from WHO criteria)
•?Patients not fulfilling criteria for severe malaria but with another indication for parenteral antimalarial treatment at the discretion of the treating physician
•?Haematocrit <15% at screening (For Gambia, Rwanda sites only: For subjects =12 years – Haematocrit <20% at screening)
•?Subjects who have received artemisinin or a derivative within the previous 7 days OR lumefantrine or amodiaquine within the previous 14 days OR mefloquine or piperaquine within the previous 30 days
•?In applicable countries: use of seasonal malaria chemoprophylaxis (SMC) within the last 14 days.
•?Acute illness other than malaria requiring systemic treatment;
•?Severe acute malnutrition (in Niger only – only those patients with Severe Acute Malnutrition and complications requiring inpatient nutritional treatment will be excluded)
•?Known HIV infection
•?Known tuberculosis infection
•?For females: post-menarche (For Gambia, Rwanda sites only: females who are pregnant, trying to get pregnant or are lactating)
•?History of allergy or known contraindication to any of the study drugs, including neuropsychiatric disorders and epilepsy
•?Previous splenectomy
•?Enrolment in DeTACT in the previous 3 months
•?Participation in another interventional study in the previous 3 months

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