A randomized trial of artemether-lumefantrine versus mefloquine-artesunate for the treatment of uncomplicated multi-drug resistant Plasmodium falciparum on the western border of Thailand

Background: The use of antimalarial drug combinations with artemisinin derivatives is recommended to overcome drug resistance in Plasmodium falciparum. The fixed combination of oral artemether-lumefantrine, an artemisinin combination therapy (ACT) is highly effective and well tolerated. It is the on...

Full description

Saved in:
Bibliographic Details
Main Authors: Robert Hutagalung, Lucy Paiphun, Elizabeth A. Ashley, Rose McGready, Alan Brockman, Kaw L. Thwai, Pratap Singhasivanon, Thomas Jelinek, Nicholas J. White, François H. Nosten
Other Authors: Shoklo Malaria Research Unit
Format: Article
Published: 2018
Subjects:
Online Access:https://repository.li.mahidol.ac.th/handle/123456789/16552
Tags: Add Tag
No Tags, Be the first to tag this record!
Institution: Mahidol University
id th-mahidol.16552
record_format dspace
spelling th-mahidol.165522018-06-21T15:23:04Z A randomized trial of artemether-lumefantrine versus mefloquine-artesunate for the treatment of uncomplicated multi-drug resistant Plasmodium falciparum on the western border of Thailand Robert Hutagalung Lucy Paiphun Elizabeth A. Ashley Rose McGready Alan Brockman Kaw L. Thwai Pratap Singhasivanon Thomas Jelinek Nicholas J. White François H. Nosten Shoklo Malaria Research Unit Mahidol University John Radcliffe Hospital Menzies School of Health Research Institut für Tropenmedizin Immunology and Microbiology Medicine Background: The use of antimalarial drug combinations with artemisinin derivatives is recommended to overcome drug resistance in Plasmodium falciparum. The fixed combination of oral artemether-lumefantrine, an artemisinin combination therapy (ACT) is highly effective and well tolerated. It is the only registered fixed combination containing an artemisinin. The trial presented here was conducted to monitor the efficacy of the six-dose regimen of artemether-lumefantrine (ALN) in an area of multi-drug resistance, along the Thai-Myanmar border. Methods: The trial was an open-label, two-arm, randomized study comparing artemether-lumefantrine and mefloquine-artesunate for the treatment of uncomplicated falciparum malaria with 42 days of follow up. Parasite genotyping by polymerase chain reaction (PCR) was used to distinguish recrudescent from newly acquired P. falciparum infections. The PCR adjusted cure rates were evaluated by survival analysis. Results: In 2001-2002 a total of 490 patients with slide confirmed uncomplicated P. falciparum malaria were randomly assigned to receive artemether-lumefantrine (n = 245) or artesunate and mefloquine (n = 245) and were followed for 42 days. All patients had rapid initial clinical and parasitological responses. In both groups, the PCR adjusted cure rates by day 42 were high: 98.8% (95% CI 96.4, 99.6%) for artemether-lumefantrine and 96.3% (95% CI 93.1, 98.0%) for artesunate- mefloquine. Both regimens were very well tolerated with no serious adverse events observed attributable to either combination. Conclusion: Overall, this study confirms that these two artemisinin-based combinations remain highly effective and result in equivalent therapeutic responses in the treatment of highly drug-resistant falciparum malaria. © 2005 Hutagalung et al; licensee BioMed Central Ltd. 2018-06-21T08:15:10Z 2018-06-21T08:15:10Z 2005-09-22 Article Malaria Journal. Vol.4, (2005) 10.1186/1475-2875-4-46 14752875 14752875 2-s2.0-26844556914 https://repository.li.mahidol.ac.th/handle/123456789/16552 Mahidol University SCOPUS https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=26844556914&origin=inward
institution Mahidol University
building Mahidol University Library
continent Asia
country Thailand
Thailand
content_provider Mahidol University Library
collection Mahidol University Institutional Repository
topic Immunology and Microbiology
Medicine
spellingShingle Immunology and Microbiology
Medicine
Robert Hutagalung
Lucy Paiphun
Elizabeth A. Ashley
Rose McGready
Alan Brockman
Kaw L. Thwai
Pratap Singhasivanon
Thomas Jelinek
Nicholas J. White
François H. Nosten
A randomized trial of artemether-lumefantrine versus mefloquine-artesunate for the treatment of uncomplicated multi-drug resistant Plasmodium falciparum on the western border of Thailand
description Background: The use of antimalarial drug combinations with artemisinin derivatives is recommended to overcome drug resistance in Plasmodium falciparum. The fixed combination of oral artemether-lumefantrine, an artemisinin combination therapy (ACT) is highly effective and well tolerated. It is the only registered fixed combination containing an artemisinin. The trial presented here was conducted to monitor the efficacy of the six-dose regimen of artemether-lumefantrine (ALN) in an area of multi-drug resistance, along the Thai-Myanmar border. Methods: The trial was an open-label, two-arm, randomized study comparing artemether-lumefantrine and mefloquine-artesunate for the treatment of uncomplicated falciparum malaria with 42 days of follow up. Parasite genotyping by polymerase chain reaction (PCR) was used to distinguish recrudescent from newly acquired P. falciparum infections. The PCR adjusted cure rates were evaluated by survival analysis. Results: In 2001-2002 a total of 490 patients with slide confirmed uncomplicated P. falciparum malaria were randomly assigned to receive artemether-lumefantrine (n = 245) or artesunate and mefloquine (n = 245) and were followed for 42 days. All patients had rapid initial clinical and parasitological responses. In both groups, the PCR adjusted cure rates by day 42 were high: 98.8% (95% CI 96.4, 99.6%) for artemether-lumefantrine and 96.3% (95% CI 93.1, 98.0%) for artesunate- mefloquine. Both regimens were very well tolerated with no serious adverse events observed attributable to either combination. Conclusion: Overall, this study confirms that these two artemisinin-based combinations remain highly effective and result in equivalent therapeutic responses in the treatment of highly drug-resistant falciparum malaria. © 2005 Hutagalung et al; licensee BioMed Central Ltd.
author2 Shoklo Malaria Research Unit
author_facet Shoklo Malaria Research Unit
Robert Hutagalung
Lucy Paiphun
Elizabeth A. Ashley
Rose McGready
Alan Brockman
Kaw L. Thwai
Pratap Singhasivanon
Thomas Jelinek
Nicholas J. White
François H. Nosten
format Article
author Robert Hutagalung
Lucy Paiphun
Elizabeth A. Ashley
Rose McGready
Alan Brockman
Kaw L. Thwai
Pratap Singhasivanon
Thomas Jelinek
Nicholas J. White
François H. Nosten
author_sort Robert Hutagalung
title A randomized trial of artemether-lumefantrine versus mefloquine-artesunate for the treatment of uncomplicated multi-drug resistant Plasmodium falciparum on the western border of Thailand
title_short A randomized trial of artemether-lumefantrine versus mefloquine-artesunate for the treatment of uncomplicated multi-drug resistant Plasmodium falciparum on the western border of Thailand
title_full A randomized trial of artemether-lumefantrine versus mefloquine-artesunate for the treatment of uncomplicated multi-drug resistant Plasmodium falciparum on the western border of Thailand
title_fullStr A randomized trial of artemether-lumefantrine versus mefloquine-artesunate for the treatment of uncomplicated multi-drug resistant Plasmodium falciparum on the western border of Thailand
title_full_unstemmed A randomized trial of artemether-lumefantrine versus mefloquine-artesunate for the treatment of uncomplicated multi-drug resistant Plasmodium falciparum on the western border of Thailand
title_sort randomized trial of artemether-lumefantrine versus mefloquine-artesunate for the treatment of uncomplicated multi-drug resistant plasmodium falciparum on the western border of thailand
publishDate 2018
url https://repository.li.mahidol.ac.th/handle/123456789/16552
_version_ 1763497844438728704