Emerging resistance to artemisinins and their partner drugs severely threatens the treatment of falciparum malaria in Myanmar with artemisinin combination therapies. To inform drug policy, it is crucial to evaluate alternative antimalarial treatments. The investigators here propose a randomized clinical trial comparing parasite clearance parameters and efficacy of 3 days arterolane-piperaquine with standard treatment with 3 days dihydroartemisinin (DHA)-piperaquine in adult patients with uncomplicated falciparum malaria in Myanmar stratified for the presence of "K13" mutation in the infecting parasite strains.
Primary Objective: \- To assess the parasite clearance half-life of arterolane-piperaquine compared to DHA-piperaquine in patients with artemisinin resistant uncomplicated falciparum malaria, defined by presence of the "K13" mutations in the infecting parasite strain. Secondary Objectives : * To assess the therapeutic efficacy of arterolane-piperaquine and DHA-piperaquine for the treatment of uncomplicated falciparum malaria or mixed infection (P.falciparum (PF) + a non-falciparum species) at Day 42, stratified by presence of artemisinin resistance in the infecting parasite strain. * To assess the frequency of adverse events and serious adverse events of arterolane-piperaquine compared to DHA-piperaquine. * To assess other efficacy parameters related to parasite clearance and parasite cure rate as well as the gametocyte carriage. * To obtain pharmacokinetic (PK) and pharmacokinetic/pharmacodynamics (PK/PD) data on arterolane-piperaquine and DHA-piperaquine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Peripheral blood parasite half-life
Peripheral blood parasite half-life of the linear portion of the natural logarithm parasite clearance curve in patients with parasitaemia at inclusion \>10,000 parasites/µL
Time frame: 2 years
42 day PCR corrected adequate clinical and parasitological response (ACPR)
Time frame: 42 days
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