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Malaria Research and Treatment
Volume 2017, Article ID 3958765, 8 pages
https://doi.org/10.1155/2017/3958765
Clinical Study

Sustained Effectiveness of a Fixed-Dose Combination of Artesunate and Amodiaquine in 480 Patients with Uncomplicated Plasmodium falciparum Malaria in Côte d’Ivoire

1Institut Pierre Richet (IPR)/Institut National de Santé Publique (INSP), Bouaké, Côte d’Ivoire
2National Malaria Control Programme, Abidjan, Côte d’Ivoire
3Infectious and Tropical Diseases Unit, Treichville University Hospital, Abidjan, Côte d’Ivoire
4Infectious and Tropical Diseases Department, Bouaké University Hospital, Bouaké, Côte d’Ivoire
5Institut Pasteur de Côte d’Ivoire, Unité de Paludologie, Abidjan, Côte d’Ivoire
6Diagnostic and Research Center on AIDS and Other Infectious Diseases (CeDReS), Abidjan, Côte d’Ivoire
7Pharmacovigilance Unit, Medical Sciences, Felix Houphouët-Boigny, Abidjan, Côte d’Ivoire
8Medicines for Malaria Venture, Geneva, Switzerland
9Sanofi Access to Medicines, Gentilly, France

Correspondence should be addressed to Serge Brice Assi; rf.oohay@igresissa

Received 8 June 2017; Accepted 10 October 2017; Published 7 December 2017

Academic Editor: Ananias Escalante

Copyright © 2017 Serge Brice Assi et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

The objective of this study was to monitor the effectiveness of artesunate-amodiaquine fixed-dose combination tablets (ASAQ Winthrop®) in the treatment of uncomplicated Plasmodium falciparum malaria in Côte d’Ivoire. Two enrolment periods (November 2009 to May 2010 and March to October 2013) were compared using an identical design. Subjects with proven monospecific P. falciparum infection according to the WHO diagnostic criteria were eligible. 290 patients during each period received a dose of ASAQ Winthrop tablets appropriate for their age. The primary outcome measure was PCR-corrected adequate clinical and parasitological response at Day 28 in the per protocol population (255 in Period 1 and 240 in Period 2). This was achieved by 95.7% of patients during Period 1 and 96.3% during Period 2. Over 95% of patients were afebrile at Day 3 and complete parasite clearance was achieved at Day 3 in >99% of patients. Nineteen adverse events in nineteen patients were considered as possibly related to treatment, principally vomiting, abnormal liver function tests, and pruritus. There was no evidence for loss of effectiveness over the three-year period in spite of strong drug pressure. This trial was registered in the US Clinical Trials Registry (clinical.trials.gov) under the identifier number NCT01023399.