Treatment of acute uncomplicated falciparum malaria with artemether-lumefantrine in non-immune populations: A safety, efficacy, and pharmacokinetic study

Hatz, Christoph; Soto, Jaime; Nothdurft, Hans Dieter; Zoller, Thomas; Weitzel, Thomas; Loutan, Louis; Bricaire, Francois; Gay, Frederick; Burchard, Gerd-Dieter; Andriano, Kim; Lefevre, Gilbert; De Palacios, Patricia Lbarra; Genton, Blaise

Abstract

The efficacy and safety of artemether-lumefantrine for the treatment of malaria in non-immune populations are not well defined. In this study, 165 non-immune 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 non-immune patients.

Más información

Título según WOS: ID WOS:000252969300016 Not found in local WOS DB
Título de la Revista: AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE
Volumen: 78
Número: 2
Editorial: AMER SOC TROP MED & HYGIENE
Fecha de publicación: 2008
Página de inicio: 241
Página final: 247
DOI:

10.4269/ajtmh.2008.78.241

Notas: ISI