Last Updated: 18/02/2026
A randomized comparative study to assess the effectiveness and tolerability of artesunate-amodiaquine versus chloroquine for uncomplicated P. vivax malaria
Objectives
Primary: To demonstrate the noninferiority of ASAQ versus chloroquine with respect to polymerase chain reaction (PCR)-adjusted adequate clinical and parasitological response (ACPR) at Day 28 (D28).
Secondary: To assess noninferiority with respect to ACPR at D28 before PCR-adjusted cure rate and at D14 and D42 before and after PCR-adjusted cure rate.
Doctor Heitor Vieira Dourado Foundation for Tropical Medicine (FMT-HVD), Brazil
Despite increasing evidence of the development of Plasmodium vivax chloroquine (CQ) resistance, there have been no trials comparing its efficacy with that of artemisinin-based combination therapies (ACTs) in Latin America.
This was a randomized, open-label, 2 parallel-arm trial comparing ASAQ to chloroquine in adults and children over 6 months old with a symptomatic, biologically confirmed P. vivax mono-infection.
Results
- ASAQ demonstrated noninferiority to chloroquine for PCR-adjusted ACPR at Day 28.
- At Day 42, ASAQ showed significantly higher efficacy than chloroquine.
- ASAQ achieved faster parasite and fever clearance.
- The results indicate the presence of chloroquine resistance in the study setting.
- Safety profiles were comparable between regimens.
Jan 2011 — Dec 2013
$335,429
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