Efficacy and Safety of Artemisinin-based Combination Treatments in the Democratic Republic of the Congo
Summary
The Democratic Republic of the Congo (DRC) is among the countries most affected by malaria in Sub-Saharan Africa. Condidering its size and the geographic position, the DRC is meant to play a major role in the malaria control in the region. The National Malaria Control program recommends artemisinin-based combination treatments (ACTs), in particular artesunate-amodiaquine or artemether-lumefrantrine for the treatment of uncomplicated malaria. Previous studies indicated that ACTs are still effective, with efficacy above the required threshold of 90%. It is required to assess regularly the efficacy of antimalarial drugs, in order to ascertain the relevance of treatment guidelines such that, in case of increasing failure rates, alternative options can be decided ontime. The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ Winthrop®), artemether-lumefantrine (Coartem Dispersible®) and dihydro-artemisinin-piperaquine (Eurartesim®) at day 42 in the treatment of uncomplicated Plasmodium falciparum malaria in six surveillance sites around DRC.
Timeline
- Start
- 2017-03-15
- Primary completion
- 2018-01-02
- Completion
- 2018-01-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ARTENIMOL | Small molecule | 10 mg | — |
| Subject | ARTENIMOL | Small molecule | 20 mg | — |
| Subject | ARTENIMOL | Small molecule | 40 mg | — |
| Subject | Artemether | Small molecule | 20 mg | — |
| Subject | Artemether | Small molecule | 40 mg | — |
| Subject | Artemether | Small molecule | 60 mg | — |
| Subject | Artesunate | Small molecule | 25 mg | — |
| Subject | Artesunate | Small molecule | 50 mg | — |
| Subject | amodiaquine | Other / unclassified | 67.5 mg | — |
| Subject | amodiaquine | Other / unclassified | 135 mg | — |
| Subject | lumefantrine | Small molecule | 120 mg | — |
| Subject | lumefantrine | Small molecule | 240 mg | — |
| Subject | lumefantrine | Small molecule | 360 mg | — |
| Subject | piperaquine | Small molecule | 80 mg | — |
| Subject | piperaquine | Small molecule | 160 mg | — |
| Subject | piperaquine | Small molecule | 320 mg | — |