A randomized, open-label, comparative efficacy trial of artemether-lumefantrine suspension versus artemether-lumefantrine tablets for treatment of uncomplicated Plasmodium falciparum malaria in children in western Kenya
Abstract Background Artemether/lumefantrine (AL) has been adopted as the treatment of choice for uncomplicated malaria in Kenya and other countries in the region. Six-dose artemether/lumefantrine tablets are highly effective and safe for the treatment of infants and children weighing between five an...
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ftdoajarticles:oai:doaj.org/article:0e28f106e3454cdc9810cea1a2771ac1 2023-05-15T15:12:00+02:00 A randomized, open-label, comparative efficacy trial of artemether-lumefantrine suspension versus artemether-lumefantrine tablets for treatment of uncomplicated Plasmodium falciparum malaria in children in western Kenya Akhwale Willis S Obonyo Charles O Juma Elizabeth A Ogutu Bernhards R 2008-12-01T00:00:00Z https://doi.org/10.1186/1475-2875-7-262 https://doaj.org/article/0e28f106e3454cdc9810cea1a2771ac1 EN eng BMC http://www.malariajournal.com/content/7/1/262 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-7-262 1475-2875 https://doaj.org/article/0e28f106e3454cdc9810cea1a2771ac1 Malaria Journal, Vol 7, Iss 1, p 262 (2008) Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 article 2008 ftdoajarticles https://doi.org/10.1186/1475-2875-7-262 2022-12-30T22:43:48Z Abstract Background Artemether/lumefantrine (AL) has been adopted as the treatment of choice for uncomplicated malaria in Kenya and other countries in the region. Six-dose artemether/lumefantrine tablets are highly effective and safe for the treatment of infants and children weighing between five and 25 kg with uncomplicated Plasmodium falciparum malaria. However, oral paediatric formulations are urgently needed, as the tablets are difficult to administer to young children, who cannot swallow whole tablets or tolerate the bitter taste of the crushed tablets. Methods A randomized, controlled, open-label trial was conducted comparing day 28 PCR corrected cure-rates in 245 children aged 6–59 months, treated over three days with either six-dose of artemether/lumefantrine tablets (Coartem ® ) or three-dose of artemether/lumefantrine suspension (Co-artesiane ® ) for uncomplicated falciparum malaria in western Kenya. The children were followed-up with clinical, parasitological and haematological evaluations over 28 days. Results Ninety three percent (124/133) and 90% (121/134) children in the AL tablets and AL suspension arms respectively completed followed up. A per protocol analysis revealed a PCR-corrected parasitological cure rate of 96.0% at Day 28 in the AL tablets group and 93.4% in the AL suspension group, p = 0.40. Both drugs effectively cleared gametocytes and were well tolerated, with no difference in the overall incidence of adverse events. Conclusion The once daily three-dose of artemether-lumefantrine suspension (Co-artesiane ® ) was not superior to six-dose artemether-lumefantrine tablets (Coartem ® ) for the treatment of uncomplicated malaria in children below five years of age in western Kenya. Trial registration ClinicalTrials.gov NCT00529867 Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Malaria Journal 7 1 |
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Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
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Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
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Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 Akhwale Willis S Obonyo Charles O Juma Elizabeth A Ogutu Bernhards R A randomized, open-label, comparative efficacy trial of artemether-lumefantrine suspension versus artemether-lumefantrine tablets for treatment of uncomplicated Plasmodium falciparum malaria in children in western Kenya |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
description |
Abstract Background Artemether/lumefantrine (AL) has been adopted as the treatment of choice for uncomplicated malaria in Kenya and other countries in the region. Six-dose artemether/lumefantrine tablets are highly effective and safe for the treatment of infants and children weighing between five and 25 kg with uncomplicated Plasmodium falciparum malaria. However, oral paediatric formulations are urgently needed, as the tablets are difficult to administer to young children, who cannot swallow whole tablets or tolerate the bitter taste of the crushed tablets. Methods A randomized, controlled, open-label trial was conducted comparing day 28 PCR corrected cure-rates in 245 children aged 6–59 months, treated over three days with either six-dose of artemether/lumefantrine tablets (Coartem ® ) or three-dose of artemether/lumefantrine suspension (Co-artesiane ® ) for uncomplicated falciparum malaria in western Kenya. The children were followed-up with clinical, parasitological and haematological evaluations over 28 days. Results Ninety three percent (124/133) and 90% (121/134) children in the AL tablets and AL suspension arms respectively completed followed up. A per protocol analysis revealed a PCR-corrected parasitological cure rate of 96.0% at Day 28 in the AL tablets group and 93.4% in the AL suspension group, p = 0.40. Both drugs effectively cleared gametocytes and were well tolerated, with no difference in the overall incidence of adverse events. Conclusion The once daily three-dose of artemether-lumefantrine suspension (Co-artesiane ® ) was not superior to six-dose artemether-lumefantrine tablets (Coartem ® ) for the treatment of uncomplicated malaria in children below five years of age in western Kenya. Trial registration ClinicalTrials.gov NCT00529867 |
format |
Article in Journal/Newspaper |
author |
Akhwale Willis S Obonyo Charles O Juma Elizabeth A Ogutu Bernhards R |
author_facet |
Akhwale Willis S Obonyo Charles O Juma Elizabeth A Ogutu Bernhards R |
author_sort |
Akhwale Willis S |
title |
A randomized, open-label, comparative efficacy trial of artemether-lumefantrine suspension versus artemether-lumefantrine tablets for treatment of uncomplicated Plasmodium falciparum malaria in children in western Kenya |
title_short |
A randomized, open-label, comparative efficacy trial of artemether-lumefantrine suspension versus artemether-lumefantrine tablets for treatment of uncomplicated Plasmodium falciparum malaria in children in western Kenya |
title_full |
A randomized, open-label, comparative efficacy trial of artemether-lumefantrine suspension versus artemether-lumefantrine tablets for treatment of uncomplicated Plasmodium falciparum malaria in children in western Kenya |
title_fullStr |
A randomized, open-label, comparative efficacy trial of artemether-lumefantrine suspension versus artemether-lumefantrine tablets for treatment of uncomplicated Plasmodium falciparum malaria in children in western Kenya |
title_full_unstemmed |
A randomized, open-label, comparative efficacy trial of artemether-lumefantrine suspension versus artemether-lumefantrine tablets for treatment of uncomplicated Plasmodium falciparum malaria in children in western Kenya |
title_sort |
randomized, open-label, comparative efficacy trial of artemether-lumefantrine suspension versus artemether-lumefantrine tablets for treatment of uncomplicated plasmodium falciparum malaria in children in western kenya |
publisher |
BMC |
publishDate |
2008 |
url |
https://doi.org/10.1186/1475-2875-7-262 https://doaj.org/article/0e28f106e3454cdc9810cea1a2771ac1 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Malaria Journal, Vol 7, Iss 1, p 262 (2008) |
op_relation |
http://www.malariajournal.com/content/7/1/262 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-7-262 1475-2875 https://doaj.org/article/0e28f106e3454cdc9810cea1a2771ac1 |
op_doi |
https://doi.org/10.1186/1475-2875-7-262 |
container_title |
Malaria Journal |
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7 |
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1 |
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1766342763447582720 |