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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion criteria:

• Adults and children over 6 months old and bodyweight > 5 kg

• Able to be treated by oral route

• Axillary temperature ≥ 37,5 C or history of fever during the previous 2 days

• Symptomatic biologically confirmed Plasmodium vivax mono-infection, with parasitemia from 250 to 100000 parasites /µl of blood

• Written informed consent of the patients and for children written informed consent of the parents/legal representative for children. Children able to understand the objectives and the risks of the study will sign an assent form.

Exclusion criteria:

• Known project of leaving the investigator site area during the follow-up period (42 days)

• Hypersensitivity to one of the investigational medicinal products or to any of the excipients

• Intake of an antimalarial treatment in the previous 30 days

• History of hepatic and (or) haematological impairment during treatment with amodiaquine

• Blurred vision suggesting a retinopathy

• Presence of at least one danger sign of malaria

• Pregnant or breast-feeding women

• Women with childbearing potential not willing to use an effective contraceptive method(s) for the duration of the study

• Known severe concomitant or underlying disease

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.