Uncomplicated Falciparum Malaria Clinical Trial
Official title:
An Open-label Randomized Trial to Assess the Therapeutic Efficacy of Arterolane-piperaquine Versus Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Falciparum Malaria in Eastern Myanmar, an Area of Emerging Artemisinin-resistant Falciparum Malaria
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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