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

• Status: Completed
• Trial end date: 2013-06-01

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

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Treatments: Amodiaquine; Artemisinins; Artesunate; Chloroquine; Chloroquine diphosphate