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Clinical Trial
. 2012 Dec 27:11:433.
doi: 10.1186/1475-2875-11-433.

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

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 et al. Malar J. .

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.

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Figures

Figure 1
Figure 1
Trial profile.
Figure 2
Figure 2
Kaplan-Meir survival estimates of PCR adjusted ACPR by treatment arm – ITT analysis.
Figure 3
Figure 3
Patients carrying gametocytes from day 0 to day 28 in the two groups.
See this image and copyright information in PMC

References

    1. World Health Organization. World Malaria Report. Geneva: WHO/HTM/MAL/2005.1102; 2005.
    1. World Health Organization. Les combinaisons thérapeutiques antipaludiques: Rapport d'une consultation technique de l'OMS. Geneva: WHO/CDS/RBM/2001.35; 2001.
    1. Zwang J, Olliaro P, Barennes H, Bonnet M, Brasseur P, Bukirwa H, Cohuet S, D'Alessandro U, Djimdé A, Karema C, Guthmann JP, Hamour S, Ndiaye JL, Mårtensson A, Rwagacondo C, Sagara I, Same-Ekobo A, Sirima SB, Van den Broek I, Yeka A, Taylor WR, Dorsey G, Randrianarivelojosia M. Efficacy of artesunate-amodiaquine for treating uncomplicated falciparum malaria in sub-Saharan Africa: a multi-centre analysis. Malar J. 2009;8:203. doi: 10.1186/1475-2875-8-203. - DOI - PMC - PubMed
    1. World Health Organization. Assessment and monitoring of antimalarial drug efficacy for the treatment of uncomplicated falciparum malaria. Geneva: WHO/HTM/RBM/2003.50; 2003.
    1. World Health Organization. Severe falciparum malaria. Geneva: WHO/HTM/RBM/2003.50; 2003.

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