NCT06076213

Test Efficacy Study on the Recommended Antimalarial Drugs in the Democratic Republic of the Congo

Efficacy and Safety of Artesunate-amodiaquine and Artemether-lumefantrine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Democratic Republic of the Congo: a Randomized Controlled Trial (TES2022)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,260 (actual)
• Sponsor: Ministry of Public Health, Democratic Republic of the Congo · Other Government
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Uncomplicated Plasmodium Falciparum Malaria

Interventions

Type	Name	Description
DRUG	Artesunate-amodiaquine	Tablets
DRUG	Artemether-lumefantrine	Tablets

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-09-24
• Completion: 2024-09-30
• First posted: 2023-10-10
• Last updated: 2024-11-05

Locations

7 sites across 1 country: Democratic Republic of the Congo