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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 Faye1*, Thomas Kuété2, Christiane P Kiki-Barro3, Roger C Tine1, Thérèse Nkoa4, Jean Louis A Ndiaye1, Claude A Kakpo5, Khadime Sylla1, Hervé EI Menan3, Oumar Gaye1, Oumar Faye1, Albert Same-Ekobo6 and Koné Moussa3

Author Affiliations

1 Service de Parasitologie-Mycologie, Faculté de Médecine, Université Cheikh Anta Diop, Dakar Fann, Dakar, BP 5005, Sénégal

2 Faculté de Médecine et Sciences Pharmaceutiques, Université de Douala, BP: 2701, Douala, Cameroun

3 Laboratoire de Parasitologie-Mycologie, UFR des Sciences Pharmaceutiques et BiologiquesUniversité de Cocody CeDReS, CHU de Treichville, Abidjan, 01 B.P.V 34, Côte d'Ivoire

4 Faculté de Médecine et Sciences Biomédicales, Université de Yaoundé 1, BP 3266, Yaoundé, Cameroun

5 Centre de Santé El RAPHA, 13 B.P 3199, Abidjan, Côte d'Ivoire

6 Centre Hospitalier Universitaire de Yaoundé, BP 3266, Yaoundé, Cameroun

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Malaria Journal 2012, 11:433  doi:10.1186/1475-2875-11-433

Published: 27 December 2012

Abstract

Background

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 Paediatric®) in suspension form versus artemether/lumefantrine (AL)(Coartem®) in the management of African children with uncomplicated falciparum malaria.

Methods

It 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).

Results

At 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.

Conclusion

This 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.

Keywords:
Malaria; Children; Artesunate plus Amodiaquine; West Africa