Tolerability and safety of artesunate-amodiaquine and artemether-lumefantrine fixed dose combinations for the treatment of uncomplicated Plasmodium falciparum malaria: two open-label, randomized trials in Nimba County, Liberia
| Autor: | Gwenaelle Carn, Eric Comte, Elizabeth A. Ashley, Elisabeth Baudin, Richard G. Smith, Loretxu Pinoges, Yah Zolia, Vincent Jullien, Michel Branger, Joel J. Jones, Birgit Schramm, Jean-René Kiechel, Charles S Mazinda, Arnaud Bruneel, Philippe J Guerin, Parastou Valeh, Timothy Sundaygar |
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| Přispěvatelé: | Epicentre [Paris] [Médecins Sans Frontières], National Malaria Control Programme, Ministry of Health and Social Welfare, Médecins Sans Frontières, Biochimie Métabolique et Cellulaire, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Service de Virologie, Epilepsies de l'Enfant et Plasticité Cérébrale (U1129), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Drugs for Neglected Diseases Initiative, Nuffield Department of Clinical Medicine [Oxford], University of Oxford [Oxford], This work was supported by Drugs for Neglected Diseases Initiative (DNDi) and Médecins Sans Frontières, Switzerland., University of Oxford, BMC, Ed., Assistance publique - Hôpitaux de Paris (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris]-Université Paris Diderot - Paris 7 ( UPD7 ), Epilepsies de l'Enfant et Plasticité Cérébrale ( U1129 ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Commissariat à l'énergie atomique et aux énergies alternatives ( CEA ) -Université Paris Descartes - Paris 5 ( UPD5 ), Centre for Tropical Medicine ( CCVTM ), University of Oxford [Oxford]-Nuffield Department of Clinical Medicine |
| Jazyk: | angličtina |
| Předmět: |
Male
Artemether/lumefantrine law.invention 0302 clinical medicine Randomized controlled trial law [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases 030212 general & internal medicine Malaria Falciparum Child Artesunate/amodiaquine Middle Aged Tolerability Artemisinins 3. Good health [ SDV.MHEP.MI ] Life Sciences [q-bio]/Human health and pathology/Infectious diseases Drug Combinations Infectious Diseases Ethanolamines Child Preschool [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases Vomiting Female Artemisinin medicine.symptom Randomized trial medicine.drug Adult medicine.medical_specialty Adolescent Nausea 030231 tropical medicine Amodiaquine 03 medical and health sciences Antimalarials Young Adult Internal medicine medicine Humans Fluorenes business.industry Research Artemether Lumefantrine Drug Combination Infant medicine.disease Liberia Surgery Malaria Parasitology business |
| Zdroj: | Malaria Journal Malaria Journal, BioMed Central, 2013, 12 (1), pp.250. ⟨10.1186/1475-2875-12-250⟩ Malaria Journal, 2013, 12 (1), pp.250. ⟨10.1186/1475-2875-12-250⟩ Malaria Journal, BioMed Central, 2013, 12 (1), pp.250. 〈10.1186/1475-2875-12-250〉 |
| ISSN: | 1475-2875 |
| DOI: | 10.1186/1475-2875-12-250 |
| Popis: | Safety surveillance of widely used artemisinin-based combination therapy (ACT) is essential, but tolerability data in the over five years age group are largely anecdotal. Two open-label, randomized trials were conducted in Nimba County, Liberia: i) the main tolerability trial with 1,000 Plasmodium falciparum malaria patients aged over five years (Study-T), and, ii) an efficacy trial with a secondary objective of collecting tolerability data among 300 children age six to 59 months (Study-E). In both studies patients were randomized to fixed-dose artesunate-amodiaquine (ASAQ Winthrop®) or artemether-lumefantrine (AL, Coartem®), respectively. Clinical- and laboratory-adverse events (AEs) were recorded until day 28. Study-T: most patients experienced at least one AE. Severe AEs were few, primarily asymptomatic blood system disorders or increased liver enzyme values. No treatment or study discontinuation occurred. Mild or moderate fatigue (39.8% vs 16.3%, p |
| Databáze: | OpenAIRE |
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