Compliance, Safety, and Effectiveness of Fixed-Dose Artesunate-Amodiaquine for Presumptive Treatment of Non-Severe Malaria in the Context of Home Management of Malaria in Madagascar

Arsène Ratsimbasoa Ministère de la Santé, du Planning Familial et de la Protection Sociale, Antananarivo, Madagascar; Malaria Unit Research, Institut Pasteur de Madagascar, Antananarivo, Madagascar; Université d'Antananarivo, Antananarivo, Madagascar; Centre René Labusquière, Université Victor Segalen, Bordeaux 2, Bordeaux, France; EA Pharmaceuticals and Analytical Methods for Neglected Diseases and Counterfeit Drugs, Bordeaux 2 University, Bordeaux, France; Malaria Molecular Epidemiology Unit, Institut Pasteur du Cambodge, Phnom Penh, Cambodia

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Harintsoa Ravony Ministère de la Santé, du Planning Familial et de la Protection Sociale, Antananarivo, Madagascar; Malaria Unit Research, Institut Pasteur de Madagascar, Antananarivo, Madagascar; Université d'Antananarivo, Antananarivo, Madagascar; Centre René Labusquière, Université Victor Segalen, Bordeaux 2, Bordeaux, France; EA Pharmaceuticals and Analytical Methods for Neglected Diseases and Counterfeit Drugs, Bordeaux 2 University, Bordeaux, France; Malaria Molecular Epidemiology Unit, Institut Pasteur du Cambodge, Phnom Penh, Cambodia

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Jeanne-Aimée Vonimpaisomihanta Ministère de la Santé, du Planning Familial et de la Protection Sociale, Antananarivo, Madagascar; Malaria Unit Research, Institut Pasteur de Madagascar, Antananarivo, Madagascar; Université d'Antananarivo, Antananarivo, Madagascar; Centre René Labusquière, Université Victor Segalen, Bordeaux 2, Bordeaux, France; EA Pharmaceuticals and Analytical Methods for Neglected Diseases and Counterfeit Drugs, Bordeaux 2 University, Bordeaux, France; Malaria Molecular Epidemiology Unit, Institut Pasteur du Cambodge, Phnom Penh, Cambodia

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Rogelin Raherinjafy Ministère de la Santé, du Planning Familial et de la Protection Sociale, Antananarivo, Madagascar; Malaria Unit Research, Institut Pasteur de Madagascar, Antananarivo, Madagascar; Université d'Antananarivo, Antananarivo, Madagascar; Centre René Labusquière, Université Victor Segalen, Bordeaux 2, Bordeaux, France; EA Pharmaceuticals and Analytical Methods for Neglected Diseases and Counterfeit Drugs, Bordeaux 2 University, Bordeaux, France; Malaria Molecular Epidemiology Unit, Institut Pasteur du Cambodge, Phnom Penh, Cambodia

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Martial Jahevitra Ministère de la Santé, du Planning Familial et de la Protection Sociale, Antananarivo, Madagascar; Malaria Unit Research, Institut Pasteur de Madagascar, Antananarivo, Madagascar; Université d'Antananarivo, Antananarivo, Madagascar; Centre René Labusquière, Université Victor Segalen, Bordeaux 2, Bordeaux, France; EA Pharmaceuticals and Analytical Methods for Neglected Diseases and Counterfeit Drugs, Bordeaux 2 University, Bordeaux, France; Malaria Molecular Epidemiology Unit, Institut Pasteur du Cambodge, Phnom Penh, Cambodia

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Rabenja Rapelanoro Ministère de la Santé, du Planning Familial et de la Protection Sociale, Antananarivo, Madagascar; Malaria Unit Research, Institut Pasteur de Madagascar, Antananarivo, Madagascar; Université d'Antananarivo, Antananarivo, Madagascar; Centre René Labusquière, Université Victor Segalen, Bordeaux 2, Bordeaux, France; EA Pharmaceuticals and Analytical Methods for Neglected Diseases and Counterfeit Drugs, Bordeaux 2 University, Bordeaux, France; Malaria Molecular Epidemiology Unit, Institut Pasteur du Cambodge, Phnom Penh, Cambodia

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Jean De Dieu Marie Rakotomanga Ministère de la Santé, du Planning Familial et de la Protection Sociale, Antananarivo, Madagascar; Malaria Unit Research, Institut Pasteur de Madagascar, Antananarivo, Madagascar; Université d'Antananarivo, Antananarivo, Madagascar; Centre René Labusquière, Université Victor Segalen, Bordeaux 2, Bordeaux, France; EA Pharmaceuticals and Analytical Methods for Neglected Diseases and Counterfeit Drugs, Bordeaux 2 University, Bordeaux, France; Malaria Molecular Epidemiology Unit, Institut Pasteur du Cambodge, Phnom Penh, Cambodia

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Denis Malvy Ministère de la Santé, du Planning Familial et de la Protection Sociale, Antananarivo, Madagascar; Malaria Unit Research, Institut Pasteur de Madagascar, Antananarivo, Madagascar; Université d'Antananarivo, Antananarivo, Madagascar; Centre René Labusquière, Université Victor Segalen, Bordeaux 2, Bordeaux, France; EA Pharmaceuticals and Analytical Methods for Neglected Diseases and Counterfeit Drugs, Bordeaux 2 University, Bordeaux, France; Malaria Molecular Epidemiology Unit, Institut Pasteur du Cambodge, Phnom Penh, Cambodia

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Pascal Millet Ministère de la Santé, du Planning Familial et de la Protection Sociale, Antananarivo, Madagascar; Malaria Unit Research, Institut Pasteur de Madagascar, Antananarivo, Madagascar; Université d'Antananarivo, Antananarivo, Madagascar; Centre René Labusquière, Université Victor Segalen, Bordeaux 2, Bordeaux, France; EA Pharmaceuticals and Analytical Methods for Neglected Diseases and Counterfeit Drugs, Bordeaux 2 University, Bordeaux, France; Malaria Molecular Epidemiology Unit, Institut Pasteur du Cambodge, Phnom Penh, Cambodia

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Didier Ménard Ministère de la Santé, du Planning Familial et de la Protection Sociale, Antananarivo, Madagascar; Malaria Unit Research, Institut Pasteur de Madagascar, Antananarivo, Madagascar; Université d'Antananarivo, Antananarivo, Madagascar; Centre René Labusquière, Université Victor Segalen, Bordeaux 2, Bordeaux, France; EA Pharmaceuticals and Analytical Methods for Neglected Diseases and Counterfeit Drugs, Bordeaux 2 University, Bordeaux, France; Malaria Molecular Epidemiology Unit, Institut Pasteur du Cambodge, Phnom Penh, Cambodia

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Home management of malaria is recommended for prompt, effective antimalarial treatment in children less than five years of age. Compliance, safety, and effectiveness of the new fixed-dose artesunate-amodiaquine regimen used to treat suspected malaria were assessed in febrile children enrolled in a 24-month cohort study in two settings in Madagascar. Children with fever were asked to visit community health workers. Presumptive antimalarial treatment was given and further visits were scheduled for follow-up. The primary endpoint was the risk of clinical/parasitologic treatment failure. Secondary outcomes included fever/parasite clearance, change in hemoglobin levels, and frequency of adverse events. The global clinical cure rate was 98.4% by day 28 and 97.9% by day 42. Reported compliance was 83.4%. No severe adverse effects were observed. This study provides comprehensive data concerning the clinical cure rate obtained with artesunate-amodiaquine and evidence supporting the scaling up of home management of malaria.

Author Notes

*Address correspondence to Arsène Ratsimbasoa, Programme National de Lutte Contre le Paludisme, Ministry of Public Health, BP 1869, Antananarivo, Madagascar, E-mail: arsene.ratsimbasoa@laposte.net or Didier Ménard, Molecular Epidemiology Unit, Pasteur Institute of Cambodia, 5 Boulevard Monivong, PO Box 983, Phnom Penh, Cambodia, E-mail: dmenard@pasteur-kh.org.

Financial support: This study was supported by Population Service International, Inter-aide, the Ampasimanjeva Medical Foundation, the Ministry of Health of Madagascar (DULM, PNLP, DRS Moramanga, Manakara), ADRA, Sanofi Aventis Paris (for providing Coarsucam™), the local authorities (Ampasimpotsy, Mahatsara, Ambodivoahangy, Andramora), and SanteNet. Arsène Ratsimbasoa was supported by the Fondation Mérieux. Didier Ménard was supported by the French Ministry of Foreign Affairs.

Authors' addresses: Arsène Ratsimbasoa, Harintsoa Ravony, Jeanne-Aimée Vonimpaisomihanta, and Rogelin Raherinjafy, Ministère de la Santé, du Planning Familial et de la Protection Sociale, Antananarivo, Madagascar, E-mails: arsene.ratsimbasoa@laposte.net, niriharintsoa@yahoo.fr, vonimpaiso@yahoo.fr, and raherinjafy@yahoo.fr. Martial Jahevitra, Rabenja Rapelanoro, and Jean De Dieu Marie Rakotomanga, Université d'Antananarivo, Antananarivo, Madagascar, E-mails: mjahevitra@yahoo.fr, frapelanoro@yahoo.fr, and rktjdm@yahoo.fr. Denis Malvy, Centre René Labusquière, Université Victor Segalen Bordeaux 2, Bordeaux, France, E-mail: denis.malvy@chu-bordeaux.fr. Pascal Millet, EA Pharmaceuticals and Analytical Methods for Neglected Diseases and Counterfeit Drugs, Bordeaux 2 University, Bordeaux, France, E-mail: pascal.millet@u-bordeaux2.fr. Didier Ménard, Malaria Molecular Epidemilogy Unit, Institut Pasteur du Cambodge, Phnom Penh, Cambodia, E-mail: dmenard@pasteur-kh.org.

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