Efficacy and Tolerability of Artesunate Amodiaquine Versus Chloroquine in the Treatment of Uncomplicated Plasmodium Vivax Malaria

Summary

Primary Objective: \- To demonstrate the non-inferiority of corrected adequate clinical and parasitological response at Day 28 of Artesunate Amodiaquine (ASAQ) versus chloroquine Secondary Objectives: * To assess the non inferiority on the same way as the main criteria: * at Day 28 before corrected cure rate * at Day 14 and Day 42 before and after corrected cure rate * To compare the two groups of treatment in terms of: * Efficacy: * Proportion of aparasitaemic patients at 24, 48 an 72 hours * Proportion of afebrile patients at 24, 48 and 72 hours * Percentage of gametocyte carriers during follow-up * Evolution of the mean of gametocytes during the 42 days of follow-up * Evolution of haemoglobin value between Day 0 and Day 7, Day 0 and Day 28 * Clinical and biological tolerability: * Proportion of any adverse event * Biological safety: haematology (Red blood cells, Haemoglobin, White Blood Cells, neutrophils, platelets), biochemistry (creatinine, transaminases (alanine amino transferase/ALT), bilirubins) * ECG (electro encephalogram) (Day 0, Day 3,Day 28) only for patients 10 years old and above

Timeline

Start

2012-01

Primary completion

2013-06

Completion

2013-06

Outcome

Met primary endpoint

paper adjusted-ACPR was achieved in 100% (165/165) and 93.6% (161/172) of patients in the ASAQ and CQ arm PMID 27988484 ↗

paper difference 6.4%, 95% CI 2.7%; 10.1% PMID 27988484 ↗

paper Apart from ITT D28 assessment, superiority of ASAQ on ACPR was demonstrated. PMID 27988484 ↗

Publications

• Siqueira AM, Alencar AC, Melo GC, Magalhaes BL, Machado K, Alencar Filho AC, Kuehn A, Marques MM, Manso MC, Felger I, Vieira JL, Lameyre V, Daniel-Ribeiro CT, Lacerda MV. Fixed-Dose Artesunate-Amodiaquine Combination vs Chloroquine for Treatment of Uncomplicated Blood Stage P. vivax Infection in the Brazilian Amazon: An Open-Label Randomized, Controlled Trial. Clin Infect Dis. 2017 Jan 15;64(2):166-174. doi: 10.1093/cid/ciw706. Epub 2016 Oct 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Artesunate	Small molecule	25 mg	—
Subject	Artesunate	Small molecule	50 mg	—
Subject	Artesunate	Small molecule	100 mg	—
Subject	Artesunate	Small molecule	200 mg	—
Comparator	Chloroquine	Small molecule	7.5 mg/kg	Oral
Subject	amodiaquine	Other / unclassified	67.5 mg	—
Subject	amodiaquine	Other / unclassified	135 mg	—
Subject	amodiaquine	Other / unclassified	270 mg	—
Subject	amodiaquine	Other / unclassified	540 mg	—

Indications