An Open Label 14-Day Therapeutic Efficacy Trial of Artesunate Plus Amodiaquine for Treating Uncomplicated Falciparum Malaria in Calabar, Nigeria.
F. A. Odey1,3, M.M. Meremikwu1,3, A. Oyo-Ita2,3, C.M. Oringanje3, E.A. Iwasam, A.A. Alaribe4,
B. Oduwole3, V. Asiegbu3 and E.N.U. Ezedinachi3,5
1Department of Padiatrics, University of Calabar
2Department of Community Medicine, University of Calabar
3Institute of Tropical Disease Research and Prevention, University of Calabar Teaching Hospital, Calabar
4Department of Medical Microbiology & Parasitology, University of Calabar
5Department of Internal Medicine, University of Calabar
Abstract: Artesunate combined with amodiquine is one of the two artemisinin combined therapy (ACT) approved for treatment of uncomplicated malaria in Nigeria. It is also the first-line anti-malarial for the treatment of uncomplicated malaria in 18 African countries. The aim of this study was to assess the 14 days therapeutic efficacy of a co-packaged combination of artesunate and amodiaquine for treating uncomplicated plasmodium falciparum therapeutic efficacy trail. Children e”6 months and adults with uncomplicated plasmodium falciparum malaria were screened for enrolment. Patients with parasite density of 1,000-200,000 were enrolled into the study. All treatments were observed by a research nurse. Patients were seen on Days 1,2,3,7, and 14 for clinical assessment and laboratory tests. Data that was generated was double entered and analysed with EPI-Info version 6. Six hundred and five patients were screened and 99 consisting of 56 males and 43 females were enrolled. Fifty-two of those enrolled were under fives while 47 were 5 years and above. Ninety-two completed the study and evaluated by day 14 (49 < 5 children and 43 e”5). Therapeutic efficacy was 100% in the per protocol population. Twenty-fours after enrolment, parasitic density had dropped by over 99%. Commonest adverse event was cough. Both haematological and biochemical indices did not deviate significantly from baseline values at the end of the study. This 14-day in-vivo therapeutic efficacy trail of the combination of artesunate plus amodiaquine showed high efficacy but a longer follow-up could have detected late parasitological failures. In order to confirm the finding of this study, another trail with at least 28 days follow-up and PCR tests to differentiate recrudescence from new infections will be required.
Keywords: Artesunate, Amodiaquine, drug trail, treatment, uncomplicated malaria
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