A Phase 4 interventional study of Artesunate-amodiaquine and Artemether-lumefantrine in Uncomplicated Plasmodium Falciparum Malaria, sponsored by Ministry of Public Health, Democratic Republic of the Congo. Completed at 7 sites in Congo, The Democratic Republic of the. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by Ministry of Public Health, Democratic Republic of the Congo · Phase 4, Interventional, and Treatment
Malaria remains a public health concern, despite efforts that are invested in the disease control. The Democratic Republic of the Congo (DRC) is one of the most affected countries in Sub Saharan Africa. Artemisinin-based combination treatments (ACTs) are recommended for the treatment of uncomplicated malaria. However, reported cases of mutations that confer to Plasmodium falciparum resistance to artemisinin (the main component of ACTs) constitute a threat to malaria control, particularly in Sub Saharan Africa. Therefore, the recommendation of the World Health Organization to conduct regularly test efficacy studies in endemic countries is paramount.
The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ Winthrop®) and artemether-lumefantrine (Coartem Dispersible®) at day 28 for the treatment of uncomplicated Plasmodium falciparum malaria in eight surveillance sites around DRC.
This is a phase IV, randomized, open label, 2-arm trial. It will be performed in eight malaria sentinel sites around DRC. Children aged 6 to 59 months with confirmed Plasmodium falciparum uncomplicated malaria will be enrolled after informed consent granted by a parent or guardian. They will be randomized to receive either artesunate-amodiaquine or artemether lumefrantrine during 3 days (directly observed treatment) and then followed up until day 28. At each visit, clinical examination (including collection of safety data) will be done and malaria testing as well. Dried blood spots will also be prepared whenever microscopy is performed, in order to assess resistance markers and perform the genotyping of the parasite for PCR-adjusted efficacy. Hemoglobin level will be measured on the recruitment day and then every two weeks until day 28.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 1,260 is above the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →Ministry of Public Health, Democratic Republic of the Congo is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
tablets of ASAQ Winthrop®
Drug: Artesunate-amodiaquine
tablets of Coartem Dispersible®
Drug: Artemether-lumefantrine
Tablets
Also known as: ASAQ Winthrop®
Tablets
Also known as: Coartem Dispersible®
PCR adjusted efficacy
Absence of fever and negative blood smear during the follow-up until day 28 or new infection occurred during the follow-up.
Time frame: day 28
Proportion of adverse events and serious adverse events
Number of adverse events and serious adverse events that every participant will experience
Time frame: day 28
Prevalence of HRP2 deletion
Proportion of positive samples that fail to be detected by malaria rapid diagnostic tests due to the deletion of the related antigen
Time frame: Baseline
Prevalence of resistance markers at baseline
Proportion of samples containing different markers of resistance to different antimalarial drugs
Time frame: Baseline
Quantification of Lumefantrine
Level of lumefantrine in the blood of children who will be randomized to the Artemether-lumefantrine arm
Time frame: day 7
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Ministry of Public Health, Democratic Republic of the Congo