Author/Authors :
Brice Assi, Serge Institut Pierre Richet (IPR)/Institut National de Sant´ePublique(INSP),Bouake, Cote d’Ivoire , Franklin Nguessan, Abouo Infectious and Tropical Diseases Unit - Treichville University Hospital, Abidjan, Cote d’Ivoire , Thomas Aba, Yapo Infectious and Tropical Diseases Department - Bouak´eUniversityHospital, Bouake, Cote d’Ivoire , Offianan Toure, André Institut Pasteur de Cote d’Ivoire - Unite de Paludologie,Abidjan,Cˆote d’Ivoire , Menan, Hervé Diagnostic and Research Center on AIDS and Other Infectious Diseases (CeDReS), Abidjan, Cote d’Ivoire , Claude Yavo, Jean Pharmacovigilance Unit - Medical Sciences - Felix Houphouet-Boigny, Abidjan, Cote d’Ivoire , San, Koffi Moise National Malaria Control Programme, Abidjan, Cote d’Ivoire , Bissagnéné, Emmanuel Infectious and Tropical Diseases Unit - Treichville University Hospital, Abidjan, Cote d’Ivoire , Duparc, Stephan Medicines for Malaria Venture, Geneva, Switzerland , Lameyre, Valérie Sanofi Access to Medicines, Gentilly, France , Tanoh, Mea Antoine National Malaria Control Programme, Abidjan, Cote d’Ivoire
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 Cˆote 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.
