Malaria, Falciparum Clinical Trial
Official title:
Clinical Efficacy of Artemisinin-based Combination Therapy for Treatment of Uncomplicated Plasmodium Falciparum Malaria in North Sumatera, Indonesia and the Association of Molecular Markers With Treatment Outcomes
This is a prospective, open label, randomised controlled trial to assess the safety and efficacy of dihydroartemisinin-piperaquine and artemether-lumefantrine in children and adults with uncomplicated Plasmodium falciparum malaria infection. Molecular markers for antimalarial resistance will also be assessed and the presence of molecular markers in the parasites will be associated with treatment outcomes.
Artemisinin-based combination therapy (ACT) is the current recommended treatment by WHO for
uncomplicated falciparum malaria. It is highly effective with few adverse effects. The
artemisinin component is combined with a partner drug with a longer half-life to ensure the
clearance of the remaining parasites after rapid reduction by artemisinin.
ACT is used as first-line treatment for uncomplicated P. falciparum infection in Indonesia
since 2004. There are 3 combinations available in the country including
artesunate-amodiaquine (AS-AQ), dihydroartemisinin-piperaquine (DHA-PQ) and
artemether-lumefantrine (AL). Studies at different sites across Indonesia have shown various
efficacy. Yet, there is an increased concern of reduced susceptibility of P. falciparum to
artemisinin in neighbouring countries. Therefore, there is a need to evaluate and monitor
the efficacies of these combinations in Indonesia.
Molecular markers are an important tool for detecting and monitoring the presence of
antimalarial resistance. Their significant implication is to geographically map the extent
of resistant-parasites, thus enabling strategies for their control and elimination to be
applied before the inevitably increase in the disease burden occurs. Different markers have
been used to identify antimalarial resistance and recently a molecular marker for
artemisinin susceptibility in P. falciparum has also been proposed. The presence of these
markers in parasites from our study will also be investigated.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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