Monitoring chemosensitivity of first-line antimalarial drugs for the treatment of uncomplicated Plasmodium falciparum malaria in children aged 6 months to 12 years in Burkina Faso

Secretariat Permanent pour elimination du Paludisme0 个研究点目标入组 1,386 人开始时间: 2024年3月26日最近更新: 2024年5月27日

适应症

试验速览

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•Children of both sexes aged 6 months to 12 years inclusive;
•- Confirmation of P. falciparum mono-infection (parasitaemia between 2000 - 200,000/µl);
•- Fever (uncorrected body temperature =37.5°C or history of fever reported within the last 24 hours).
•- Hemoglobin level = 5.0 g/dl
•- Ability to take oral medication;
•- Parents' ability and willingness to comply with the protocol for the duration of the study and to respect the consultation schedule;
•- Signature (or thumbprint when parents/guardians are illiterate) of consent form by child's parents or guardians.

•- Presence of signs of severe malaria according to WHO definitions (appendix 2)
•- General danger signs in children under five (inability to drink or breastfeed, repeated vomiting (> 2 times in 24 hours), convulsions, unconsciousness, inability to sit or stand)
•- Body weight less than 5 kg;
•- Febrile state due to illnesses other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrheal disease with dehydration) or presence of other known chronic or severe underlying diseases or any other condition (e.g. heart, kidney or liver disease, HIV/AIDS) which in the judgment of the clinical investigator would place the subject at potential risk or interfere with the conduct of the study;
•- History of antimalarial treatment with ACT within the last two weeks;
•- History of taking any other antimalarial drug within 72 hours prior to the day of the visit;
•- History of hypersensitivity to any of the drugs tested;
•- Severe malnutrition (defined by a weight-for-age z-score below -3 or other clinical sign of severe malnutrition);
•- Known individual or family history of clinical QT interval prolongation or sudden death;
•- Previous participation in a malaria vaccine clinical trial;
•- Any other condition which, in the judgment of the investigator, would compromise the safety, rights or well-being of the participant or render him/her unable to comply with the protocol.

发起方

Secretariat Permanent pour elimination du Paludisme