Test Efficacy Study on the Recommended Antimalarial Drugs in the Democratic Republic of the Congo (TES2022)
Uncomplicated Plasmodium Falciparum Malaria
About this trial
This is an interventional treatment trial for Uncomplicated Plasmodium Falciparum Malaria focused on measuring Uncomplicated malaria, Plasmodium falciparum, Artemisinin-based Combination Treatment, Artemether-lumefantrine, Artesunate-amodiaquine
Eligibility Criteria
Inclusion Criteria: children aged 6 to 59 months monoinfection with Plasmodium falciparum with asexual parasite count of 2,000 to 200,000/µL axillary temperature ≥ 37.5 °C ability to swallow oral medication ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule; informed consent from a parent or a guardian living within the study catchment area absence of severe manutrition absence of infectious diseases that can be responsible of fever absence of allergy to the study drugs Exclusion Criteria: presence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO; body weight < 5kg hemoglobin level < 5g/ dL or hematocrit < 15% presence of severe malnutrition presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS); regular medication, which may interfere with antimalarial pharmacokinetics; malaria treatment within 2 days prior to recruitment history of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatment; body weight below 5 kg
Sites / Locations
- Centre de santé Lupidi 1
- Centres de santé de Mikalayi et Matamba
- Centre de santé de Coopération
- Centre de Santé de VangaRecruiting
- Centre de santé de KalimaRecruiting
- Centre Hospitalier Virunga
- Centres de santé Umoja et Foyer socialRecruiting
- Centre de santé Boende 2 Nsele
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Artesunate-amodiaquine
Artemether-lumefantrine
tablets of ASAQ Winthrop®
tablets of Coartem Dispersible®