title: Treatment of acute uncomplicated falciparum malaria with artemether-lumefantrine in nonimmune populations: a safety, efficacy, and pharmacokinetic study.
abstract: The efficacy and safety of artemether-lumefantrine for the treatment of malaria in nonimmune populations are not well defined. In this study, 165 nonimmune patients from Europe and non-malarious areas of Colombia with acute, uncomplicated falciparum malaria or mixed infection including P. falciparum were treated with the six-dose regimen of artemether-lumefantrine. The parasitologic cure rate at 28 days was 96.0% for the per protocol population (119/124 patients). Median times to parasite clearance and fever clearance were 41.5 and 36.8 hours, respectively. No patient had gametocytes after Day 7. Treatment was well tolerated; most adverse events were mild to moderate and seemed to be related to malaria. There were few serious adverse events, none of which were considered to be drug-related. No significant effects on ECG or laboratory parameters were observed. In conclusion, the six-dose regimen of artemether-lumefantrine was effective and well tolerated in the treatment of acute uncomplicated falciparum malaria in nonimmune patients.
authors.affiliation: Medical Department, Swiss Tropical Institute, Basel, Switzerland. christoph.hatz@unibas.ch
authors.forename: Christoph
authors.initials: C
authors.lastname: Hatz
authors.forename: Jaime
authors.initials: J
authors.lastname: Soto
authors.forename: Hans Dieter
authors.initials: HD
authors.lastname: Nothdurft
authors.forename: Thomas
authors.initials: T
authors.lastname: Zoller
authors.forename: Thomas
authors.initials: T
authors.lastname: Weitzel
authors.forename: Louis
authors.initials: L
authors.lastname: Loutan
authors.forename: Francois
authors.initials: F
authors.lastname: Bricaire
authors.forename: Frederick
authors.initials: F
authors.lastname: Gay
authors.forename: Gerd-Dieter
authors.initials: GD
authors.lastname: Burchard
authors.forename: Kim
authors.initials: K
authors.lastname: Andriano
authors.forename: Gilbert
authors.initials: G
authors.lastname: Lefèvre
authors.forename: Patricia Ibarra
authors.initials: PI
authors.lastname: De Palacios
authors.forename: Blaise
authors.initials: B
authors.lastname: Genton
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D000962:Antimalarials / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000592:standards / Q000627:therapeutic use*; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000592:standards / Q000627:therapeutic use*; D004338:Drug Combinations; D004983:Ethanolamines / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000592:standards / Q000627:therapeutic use*; D005260:Female; D005449:Fluorenes / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000592:standards / Q000627:therapeutic use*; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D018512:Parasitemia / Q000188:drug therapy; D010963:Plasmodium falciparum / Q000187:drug effects / Q000302:isolation & purification; D013997:Time Factors; D014195:Travel; D016896:Treatment Outcome
chemical_list: D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes