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The American Journal of Tropical Medicine and Hygiene
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0002-9637
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Treatment of Acute Uncomplicated Falciparum Malaria with Artemether-Lumefantrine in Non-immune Populations: A Safety, Efficacy, and Pharmacokinetic Study

Christoph HatzMedical Department, Swiss Tropical Institute, Basel, Switzerland; CIBIC, Centro de Investigaciones Bioclínicas, Bogotá, Colombia; Department of Tropical Medicine and Infectious Diseases, University of Munich, Munich, Germany; University Hospital Charité, Berlin, Germany; Tropeninstitut Berlin, Berlin, Germany; Hôpital Cantonal, Geneva, Switzerland; Hôpital Pitié-Salpêtrière, Paris, France; Department of Tropical Medicine, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Novartis Pharma AG, Basel, Switzerland; Travel Clinic, Medical Outpatient Clinic, Lausanne, Switzerland

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Jaime SotoMedical Department, Swiss Tropical Institute, Basel, Switzerland; CIBIC, Centro de Investigaciones Bioclínicas, Bogotá, Colombia; Department of Tropical Medicine and Infectious Diseases, University of Munich, Munich, Germany; University Hospital Charité, Berlin, Germany; Tropeninstitut Berlin, Berlin, Germany; Hôpital Cantonal, Geneva, Switzerland; Hôpital Pitié-Salpêtrière, Paris, France; Department of Tropical Medicine, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Novartis Pharma AG, Basel, Switzerland; Travel Clinic, Medical Outpatient Clinic, Lausanne, Switzerland

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Hans Dieter NothdurftMedical Department, Swiss Tropical Institute, Basel, Switzerland; CIBIC, Centro de Investigaciones Bioclínicas, Bogotá, Colombia; Department of Tropical Medicine and Infectious Diseases, University of Munich, Munich, Germany; University Hospital Charité, Berlin, Germany; Tropeninstitut Berlin, Berlin, Germany; Hôpital Cantonal, Geneva, Switzerland; Hôpital Pitié-Salpêtrière, Paris, France; Department of Tropical Medicine, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Novartis Pharma AG, Basel, Switzerland; Travel Clinic, Medical Outpatient Clinic, Lausanne, Switzerland

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Thomas ZollerMedical Department, Swiss Tropical Institute, Basel, Switzerland; CIBIC, Centro de Investigaciones Bioclínicas, Bogotá, Colombia; Department of Tropical Medicine and Infectious Diseases, University of Munich, Munich, Germany; University Hospital Charité, Berlin, Germany; Tropeninstitut Berlin, Berlin, Germany; Hôpital Cantonal, Geneva, Switzerland; Hôpital Pitié-Salpêtrière, Paris, France; Department of Tropical Medicine, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Novartis Pharma AG, Basel, Switzerland; Travel Clinic, Medical Outpatient Clinic, Lausanne, Switzerland

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Thomas WeitzelMedical Department, Swiss Tropical Institute, Basel, Switzerland; CIBIC, Centro de Investigaciones Bioclínicas, Bogotá, Colombia; Department of Tropical Medicine and Infectious Diseases, University of Munich, Munich, Germany; University Hospital Charité, Berlin, Germany; Tropeninstitut Berlin, Berlin, Germany; Hôpital Cantonal, Geneva, Switzerland; Hôpital Pitié-Salpêtrière, Paris, France; Department of Tropical Medicine, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Novartis Pharma AG, Basel, Switzerland; Travel Clinic, Medical Outpatient Clinic, Lausanne, Switzerland

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Louis LoutanMedical Department, Swiss Tropical Institute, Basel, Switzerland; CIBIC, Centro de Investigaciones Bioclínicas, Bogotá, Colombia; Department of Tropical Medicine and Infectious Diseases, University of Munich, Munich, Germany; University Hospital Charité, Berlin, Germany; Tropeninstitut Berlin, Berlin, Germany; Hôpital Cantonal, Geneva, Switzerland; Hôpital Pitié-Salpêtrière, Paris, France; Department of Tropical Medicine, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Novartis Pharma AG, Basel, Switzerland; Travel Clinic, Medical Outpatient Clinic, Lausanne, Switzerland

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Francois BricaireMedical Department, Swiss Tropical Institute, Basel, Switzerland; CIBIC, Centro de Investigaciones Bioclínicas, Bogotá, Colombia; Department of Tropical Medicine and Infectious Diseases, University of Munich, Munich, Germany; University Hospital Charité, Berlin, Germany; Tropeninstitut Berlin, Berlin, Germany; Hôpital Cantonal, Geneva, Switzerland; Hôpital Pitié-Salpêtrière, Paris, France; Department of Tropical Medicine, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Novartis Pharma AG, Basel, Switzerland; Travel Clinic, Medical Outpatient Clinic, Lausanne, Switzerland

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Frederick GayMedical Department, Swiss Tropical Institute, Basel, Switzerland; CIBIC, Centro de Investigaciones Bioclínicas, Bogotá, Colombia; Department of Tropical Medicine and Infectious Diseases, University of Munich, Munich, Germany; University Hospital Charité, Berlin, Germany; Tropeninstitut Berlin, Berlin, Germany; Hôpital Cantonal, Geneva, Switzerland; Hôpital Pitié-Salpêtrière, Paris, France; Department of Tropical Medicine, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Novartis Pharma AG, Basel, Switzerland; Travel Clinic, Medical Outpatient Clinic, Lausanne, Switzerland

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Gerd-Dieter BurchardMedical Department, Swiss Tropical Institute, Basel, Switzerland; CIBIC, Centro de Investigaciones Bioclínicas, Bogotá, Colombia; Department of Tropical Medicine and Infectious Diseases, University of Munich, Munich, Germany; University Hospital Charité, Berlin, Germany; Tropeninstitut Berlin, Berlin, Germany; Hôpital Cantonal, Geneva, Switzerland; Hôpital Pitié-Salpêtrière, Paris, France; Department of Tropical Medicine, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Novartis Pharma AG, Basel, Switzerland; Travel Clinic, Medical Outpatient Clinic, Lausanne, Switzerland

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Kim AndrianoMedical Department, Swiss Tropical Institute, Basel, Switzerland; CIBIC, Centro de Investigaciones Bioclínicas, Bogotá, Colombia; Department of Tropical Medicine and Infectious Diseases, University of Munich, Munich, Germany; University Hospital Charité, Berlin, Germany; Tropeninstitut Berlin, Berlin, Germany; Hôpital Cantonal, Geneva, Switzerland; Hôpital Pitié-Salpêtrière, Paris, France; Department of Tropical Medicine, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Novartis Pharma AG, Basel, Switzerland; Travel Clinic, Medical Outpatient Clinic, Lausanne, Switzerland

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Gilbert LefèvreMedical Department, Swiss Tropical Institute, Basel, Switzerland; CIBIC, Centro de Investigaciones Bioclínicas, Bogotá, Colombia; Department of Tropical Medicine and Infectious Diseases, University of Munich, Munich, Germany; University Hospital Charité, Berlin, Germany; Tropeninstitut Berlin, Berlin, Germany; Hôpital Cantonal, Geneva, Switzerland; Hôpital Pitié-Salpêtrière, Paris, France; Department of Tropical Medicine, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Novartis Pharma AG, Basel, Switzerland; Travel Clinic, Medical Outpatient Clinic, Lausanne, Switzerland

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Patricia Ibarra De PalaciosMedical Department, Swiss Tropical Institute, Basel, Switzerland; CIBIC, Centro de Investigaciones Bioclínicas, Bogotá, Colombia; Department of Tropical Medicine and Infectious Diseases, University of Munich, Munich, Germany; University Hospital Charité, Berlin, Germany; Tropeninstitut Berlin, Berlin, Germany; Hôpital Cantonal, Geneva, Switzerland; Hôpital Pitié-Salpêtrière, Paris, France; Department of Tropical Medicine, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Novartis Pharma AG, Basel, Switzerland; Travel Clinic, Medical Outpatient Clinic, Lausanne, Switzerland

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Blaise GentonMedical Department, Swiss Tropical Institute, Basel, Switzerland; CIBIC, Centro de Investigaciones Bioclínicas, Bogotá, Colombia; Department of Tropical Medicine and Infectious Diseases, University of Munich, Munich, Germany; University Hospital Charité, Berlin, Germany; Tropeninstitut Berlin, Berlin, Germany; Hôpital Cantonal, Geneva, Switzerland; Hôpital Pitié-Salpêtrière, Paris, France; Department of Tropical Medicine, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Novartis Pharma AG, Basel, Switzerland; Travel Clinic, Medical Outpatient Clinic, Lausanne, Switzerland

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DOI:
https://doi.org/10.4269/ajtmh.2008.78.241
Volume/Issue:
Volume 78: Issue 2
Page(s):
241–247
Restricted access
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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.

Author Notes

Reprint requests: Christoph Hatz, Swiss Tropical Institute, Socinstrasse 57, 4002 Basel, Switzerland. E-mail: christoph.hatz@unibas.ch.
Copyright:
Copyright 2008 The American Society of Tropical Medicine 2008
Received:
08 Jan 2007
|
Accepted:
15 Jul 2007
|
Published Online:
Feb 2008
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