Case management is one of the key strategies for malaria control in most endemic countries.
Plasmodium falciparum malaria is becoming resistant to commonly used and cheap antimalarial
drugs such as chloroquine, amodiaquine, and sulfadoxine-pyrimethamine (SP). Thus the safety
and efficacy of new anti-malarial drugs need to be tested in sites with well-characterised
malariometric indices in order to make appropriate treatment policies.
Artemisinin-based combination chemotherapies have been documented to consistently produce
faster relief of clinical symptoms and parasite clearance in uncomplicated falciparum malaria
than any other currently used antimalarial drugs. So far, artesunate-amodiaquine (AS-AQ) and
artemether-lumefantrine (AR-LM) are the only two registered fixed-dose artemisinin
combination chemotherapies produced at industrial scale, with good manufacturing practices
and already used in Africa. Several African countries, including Ghana, are therefore
introducing either AS-AQ or AR-LM as first-line antimalarials or evaluating the case for such
a change. Clearly, a direct comparison of both the safety and efficacy profiles of the two
combinations under different epidemiological conditions is urgently needed to guide informed
decisions on the most appropriate antimalarial first-line treatment regimen.
This study aims to evaluate the efficacy and safety of artesunate-amodiaquine combination
therapy, artemether-lumefantrine, and artesunate-lapdap in an open-labelled, randomised,
non-inferiority drug trial.
The study results will inform future decisions on first- and second-line treatments for
uncomplicated P. falciparum malaria with respect to efficacy and safety in Ghana.
Phase:
Phase 4
Details
Lead Sponsor:
Gates Malaria Partnership London School of Hygiene and Tropical Medicine
Collaborator:
Kintampo Health Research Centre, Ghana
Treatments:
Amodiaquine Artemether-lumefantrine combination Artemether, Lumefantrine Drug Combination Artemisinins Artesunate