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

Malaria Clinical Trial

Official title: A Randomised Comparative Study to Assess the Efficacy and Tolerability of Blood Schizonticidal Treatments With Artesunate Amodiaquine Winthrop® / Coarsucam (ASAQ) Versus Chloroquine (CQ) for Uncomplicated Plasmodium Vivax Monoinfection Malaria

Status Completed

Clinical Trial 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

Clinical Trial Description

Each patient will be followed for a period of 42 days ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

• NCT number: NCT01378286
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 3
• Start date: January 2012
• Completion date: June 2013