Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

Sanofi580 enrolled

Overview

The primary objective of this study is to demonstrate the non-inferiority of Polymerase Chain Reaction (PCR)-adjusted adequate clinical and parasitological response to artesunate plus amodiaquine at Day 28 in two groups of patients treated at the beginning of an artesunate plus amodiaquine implementation program and 24 months later. The secondary objectives are Clinical and biological tolerability Evolution of gametocyte carriage Proportion of patients without fever at Day 3 Proportion of patients without parasite at Day 3 Treatment compliance Impact of implementation on anemia Measure of parasite sensibility to amodiaquine

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

580

Conditions

Malaria

Interventions

Artesunate + AmodiaquineDRUG

Artesunate + Amodiaquine fixed dose combination

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Body weight \>=5kg * Plasmodium falciparum infection with parasite density \> 2000/µL * Fever or history of fever * Able to be treated by oral route * No signs of severe malaria * No known allergy to study drugs * No other severe illnesses or underlying diseases * No known pregnancy or negative urinary pregnancy test for women of child bearing age * No participation in another ongoing clinical study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (1)

Investigational Site Number 1

Agboville District, Côte d’Ivoire

Outcomes

Primary Outcomes

Polymerase chain reaction (PCR)-corrected and uncorrected clinical and parasitological cure rate (ACPR)

Time frame: Day 28

Secondary Outcomes

Number of patients without fever

Time frame: Day 3

Number of patients without parasite

Time frame: Day 3

Number of gametocytes

Time frame: Day 3, Day 7, Day 14, Day 21 and Day 28

Evolution of in vitro resistance rate

Time frame: Day 3, Day 7, Day 14, Day 21 and Day 28

Data from ClinicalTrials.gov

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