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01.12.2012 | Research | Ausgabe 1/2012 Open Access

Malaria Journal 1/2012

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

Zeitschrift:
Malaria Journal > Ausgabe 1/2012
Autoren:
Babacar Faye, Thomas Kuété, Christiane P Kiki-Barro, Roger C Tine, Thérèse Nkoa, Jean Louis A Ndiaye, Claude A Kakpo, Khadime Sylla, Hervé EI Menan, Oumar Gaye, Oumar Faye, Albert Same-Ekobo, Koné Moussa
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1475-2875-11-433) contains supplementary material, which is available to authorized users.

Competing interests

The investigations were financially supported by Pfizer Pharmaceutical Laboratories, West Africa, who also supplied the anti-malarials drugs used for this study.

Authors’ contribution

BF wrote the paper; BF, JLN, RCT, KS supervised field work and data collection in Senegal, analysed data of Senegal and analysed from the three countries, reviewed and approved the manuscript; TK, TN collected and analysed data in Cameroon, reviewed and approved the manuscript; EIHM, CPK, CA A collected and analysed data in Ivory Coast, reviewed and approved the manuscript; OG coordinated the study in the three countries, reviewed and approved the manuscript; OF coordinated the study in Senegal, reviewed and approved the manuscript; AS coordinated the study in Cameroon (data collection and analysis) reviewed and approved the manuscript; MK coordinated (data collection and analysis) the study in Ivory Coast, reviewed and approved the manuscript. All authors read and approved the final manuscript.

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.
Zusatzmaterial
Authors’ original file for figure 1
12936_2012_2586_MOESM1_ESM.pdf
Authors’ original file for figure 2
12936_2012_2586_MOESM2_ESM.pdf
Authors’ original file for figure 3
12936_2012_2586_MOESM3_ESM.pdf
Literatur
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