title: Efficacy and safety of artemether-lumefantrine (Coartem) tablets (six-dose regimen) in African infants and children with acute, uncomplicated falciparum malaria.
abstract: 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-<10 kg) previously exposed to malaria infection (partially immune: 88.6% uncorrected; 93.3% corrected), and in those who were non-immune (82.5% uncorrected; 95.0% corrected). Adverse events were mostly mild. There was no electrocardiographic evidence of cardiotoxicity. The co-artemether six-dose regimen, treating acute uncomplicated falciparum malaria in African children, achieved rapid parasite clearance and a high cure rate. Treatment was generally safe and well tolerated.
authors.affiliation: Malaria Research Laboratories, IMRAT, College of Medicine, University of Ibadan, Ibadan, Nigeria.
authors.forename: Catherine
authors.initials: C
authors.lastname: Falade
authors.forename: Michael
authors.initials: M
authors.lastname: Makanga
authors.forename: Zul
authors.initials: Z
authors.lastname: Premji
authors.forename: Christine-Elke
authors.initials: CE
authors.lastname: Ortmann
authors.forename: Marlies
authors.initials: M
authors.lastname: Stockmeyer
authors.forename: Patricia Ibarra
authors.initials: PI
authors.lastname: de Palacios
mesh_terms: D000208:Acute Disease; D000962:Antimalarials / Q000008:administration & dosage* / Q000009:adverse effects; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004983:Ethanolamines; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage* / Q000009:adverse effects; D006339:Heart Rate; D006403:Hematologic Tests; D006801:Humans; D007223:Infant; D007630:Kenya / Q000453:epidemiology; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000453:epidemiology / Q000276:immunology; D008297:Male; D009549:Nigeria / Q000453:epidemiology; D010270:Parasite Egg Count; D012717:Sesquiterpenes / Q000008:administration & dosage* / Q000009:adverse effects; D017678:Sex Distribution; D013636:Tanzania / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes; D012717:Sesquiterpenes