Multicentre study evaluating the non-inferiority of the new paediatric formulation of artesunate/amodiaquine versus artemether/lumefantrine for the management of uncomplicated Plasmodium falciparum malaria in children in Cameroon, Ivory Coast and Senegal

Babacar Faye,Claude A Kakpo,Thomas Kuété,Thérèse Nkoa,Oumar Faye,Roger C Tine,Jean Louis A Ndiaye,Koné Moussa,Christiane P Kiki-Barro,Albert Same-Ekobo,Hervé Ei Menan,Oumar Gaye,Khadime Sylla

doi:10.1186/1475-2875-11-433

Abstract

BackgroundThis multicentre study was carried out in Cameroon, Ivory Coast and Senegal to evaluate the non-inferiority of the new paediatric formulation of artesunate/amodiaquine (AS+AQ)(Camoquin-Plus Paediatric®) in suspension form versus artemether/lumefantrine (AL)(Coartem®) in the management of African children with uncomplicated falciparum malaria.MethodsIt was an open randomized trial including children aged between 7 months and 7 years. The endpoints were Adequate Clinical and Parasitological Response (ACPR) at day 28, the clinical and biological tolerability. Statistical analyses were done in Intention To Treat (ITT) and in Per protocol (PP).ResultsAt the end of the study 481 patients were enrolled in the three countries (249 in the AS+AQ arm and 232 in the AL arm). ACRP in ITT after PCR correction did not show any statistical difference between the two groups with 97.6% for AS+AQ versus 94.8% for AL. In the PP analysis, the corrected ACRP were respectively 98.7% and 96.9% for the two regimens. The clinical tolerance was good without significant difference. Anaemia was significantly higher at D7 in the two groups compared to D0.ConclusionThis study demonstrates the non-inferiority of AS+AQ versus AL, its efficacy and tolerance in the management of uncomplicated Plasmodium falciparum malaria in African children.

Highlights

This multicentre study was carried out in Cameroon, Ivory Coast and Senegal to evaluate the non-inferiority of the new paediatric formulation of artesunate/amodiaquine (AS+AQ)(Camoquin-Plus PaediatricW) in suspension form versus artemether/lumefantrine (AL)(CoartemW) in the management of African children with uncomplicated falciparum malaria
The main focus of this study conducted in 2008 and 2009 in three sites in West Africa (Cameroon, Ivory Coast and Senegal) was to determine the non-inferiority at day 28 of this new AS+AQ paediatric formulation versus artemether/lumefantrine (CoartemW) in the treatment of uncomplicated P. falciparum malaria among children aged between six months and seven years
Signs of severe malaria [5] or severe malnutrition, patients with allergy to study drugs or who had used any anti-malarial drug within 28 days prior to enrolment were excluded

Summary

Introduction

This multicentre study was carried out in Cameroon, Ivory Coast and Senegal to evaluate the non-inferiority of the new paediatric formulation of artesunate/amodiaquine (AS+AQ)(Camoquin-Plus PaediatricW) in suspension form versus artemether/lumefantrine (AL)(CoartemW) in the management of African children with uncomplicated falciparum malaria. Since 2006, the recommendation by WHO is to use artemisinin-based combination therapy (ACT) in response to the rise in resistance to the usual treatment (chloroquine, amodiaquine or sulphadoxine-pyrimethamine) of uncomplicated Plasmodium falciparum malaria [2]. The main focus of this study conducted in 2008 and 2009 in three sites in West Africa (Cameroon, Ivory Coast and Senegal) was to determine the non-inferiority at day 28 of this new AS+AQ paediatric formulation versus artemether/lumefantrine (CoartemW) in the treatment of uncomplicated P. falciparum malaria among children aged between six months and seven years

Methods

Results

Discussion

Conclusion