Efficacy and safety of artemether–lumefantrine (Coartem ®) tablets (six-dose regimen) in African infants and children with acute, uncomplicated falciparum malaria

Approximately one million children die from malaria each year. A recently approved artemisinin-based tablet, Coartem (co-artemether), comprising artemether 120 mg plus lumefantrine 20 mg, given in four doses, provides effective antimalarial treatment for children in many sub-Saharan countries. Howev...

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Bibliographic Details
Published in:Transactions of the Royal Society of Tropical Medicine and Hygiene 2005-06, Vol.99 (6), p.459-467
Main Authors: Falade, Catherine, Makanga, Michael, Premji, Zul, Ortmann, Christine-Elke, Stockmeyer, Marlies, de Palacios, Patricia Ibarra
Format: Article
Language:English
Subjects:
Acute Disease
Africa
Antimalarials
Antimalarials - administration & dosage
Antimalarials - adverse effects
Artemisinins - administration & dosage
Artemisinins - adverse effects
Biological and medical sciences
Child
Child, Preschool
Co-artemether
Drug Administration Schedule
Drug Combinations
Ethanolamines
Female
Fluorenes - administration & dosage
Fluorenes - adverse effects
Heart Rate
Hematologic Tests
Human protozoal diseases
Humans
Infant
Infectious diseases
Kenya - epidemiology
Malaria
Malaria, Falciparum - drug therapy
Malaria, Falciparum - epidemiology
Malaria, Falciparum - immunology
Male
Medical sciences
Nigeria - epidemiology
Parasite Egg Count
Parasitic diseases
Plasmodim falciparum
Protozoal diseases
Sesquiterpenes - administration & dosage
Sesquiterpenes - adverse effects
Sex Distribution
Tanzania - epidemiology
Time Factors
Treatment Outcome
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Summary:Approximately one million children die from malaria each year. A recently approved artemisinin-based tablet, Coartem (co-artemether), comprising artemether 120 mg plus lumefantrine 20 mg, given in four doses, provides effective antimalarial treatment for children in many sub-Saharan countries. However, this regimen is considered insufficient for non-immune infants and in areas where multidrug-resistant Plasmodium falciparum predominates. This open-label study assessed the efficacy and safety of co-artemether administered to 310 African children weighing 5–25 kg, with acute, uncomplicated falciparum malaria. Six doses of co-artemether were given over 3 days, with follow-up at 7, 14 and 28 days. Treatment rapidly cleared parasitemia and fever. The overall 28-day cure rate was 86.5%, and 93.9% when corrected by PCR for reinfection. Cure rates at 7 and 14 days exceeded 97.0% (uncorrected) and, on day 28, were similar in infants (5–
ISSN:0035-9203
1878-3503
DOI:10.1016/j.trstmh.2004.09.013