| • 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 |
80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year |
6 Month(s) |
99 Year(s) |
Both |