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Safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria at Shecha health centre, Arba Minch, Ethiopia

BACKGROUND: In 2004, Ethiopia adopted artemether-lumefantrine (AL, Coartem(®)) as first-line treatment for the management of uncomplicated Plasmodium falciparum malaria. Continuous monitoring of AL therapeutic efficacy is crucial in Ethiopia, as per the World Health Organization (WHO) recommendation...

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Autores principales: Gubae, Kale, Mohammed, Hussein, Sime, Heven, Hailgiorgis, Henok, Mare, Anteneh Kassahun, Gidey, Bokretsion, Haile, Mebrahtom, Assefa, Gudissa, Bekele, Worku, Tasew, Geremew, Abay, Solomon Mequanente, Assefa, Ashenafi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9824982/
https://www.ncbi.nlm.nih.gov/pubmed/36611179
http://dx.doi.org/10.1186/s12936-022-04436-8
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author Gubae, Kale
Mohammed, Hussein
Sime, Heven
Hailgiorgis, Henok
Mare, Anteneh Kassahun
Gidey, Bokretsion
Haile, Mebrahtom
Assefa, Gudissa
Bekele, Worku
Tasew, Geremew
Abay, Solomon Mequanente
Assefa, Ashenafi
author_facet Gubae, Kale
Mohammed, Hussein
Sime, Heven
Hailgiorgis, Henok
Mare, Anteneh Kassahun
Gidey, Bokretsion
Haile, Mebrahtom
Assefa, Gudissa
Bekele, Worku
Tasew, Geremew
Abay, Solomon Mequanente
Assefa, Ashenafi
author_sort Gubae, Kale
collection PubMed
description BACKGROUND: In 2004, Ethiopia adopted artemether-lumefantrine (AL, Coartem(®)) as first-line treatment for the management of uncomplicated Plasmodium falciparum malaria. Continuous monitoring of AL therapeutic efficacy is crucial in Ethiopia, as per the World Health Organization (WHO) recommendation. This study aimed to assess the therapeutic efficacy of AL in the treatment of uncomplicated P. falciparum infection. METHODS: A 28 day onearm, prospective evaluation of the clinical and parasitological response to AL was conducted at Shecha Health Centre, Arba Minch town, Southern Ethiopia. Patients were treated with six-dose regimen of AL over three days and monitored for 28 days with clinical and laboratory assessments. Participant recruitment and outcome classification was done in accordance with the 2009 WHO methods for surveillance of anti-malarial drug efficacy guidelines. RESULTS: A total of 88 study participants were enrolled and 69 of them completed the study with adequate clinical and parasitological response. Two late parasitological failures were observed, of which one was classified as a recrudescence by polymerase chain reaction (PCR). The PCRcorrected cure rate was 98.6% (95% CI 92.3–100). AL demonstrated a rapid parasite and fever clearance with no parasitaemia on day 2 and febrile cases on day 3. Gametocyte clearance was complete by day three. No serious adverse events were reported during the 28 days follow-up. CONCLUSION: The study demonstrated high therapeutic efficacy and good safety profile of AL. This suggests the continuation of AL as the first-line drug for the treatment of uncomplicated P. falciparum malaria in Ethiopia. Periodic therapeutic efficacy studies and monitoring of markers of resistance are recommended for early detection of resistant parasites. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12936-022-04436-8.
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spelling pubmed-98249822023-01-08 Safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria at Shecha health centre, Arba Minch, Ethiopia Gubae, Kale Mohammed, Hussein Sime, Heven Hailgiorgis, Henok Mare, Anteneh Kassahun Gidey, Bokretsion Haile, Mebrahtom Assefa, Gudissa Bekele, Worku Tasew, Geremew Abay, Solomon Mequanente Assefa, Ashenafi Malar J Research BACKGROUND: In 2004, Ethiopia adopted artemether-lumefantrine (AL, Coartem(®)) as first-line treatment for the management of uncomplicated Plasmodium falciparum malaria. Continuous monitoring of AL therapeutic efficacy is crucial in Ethiopia, as per the World Health Organization (WHO) recommendation. This study aimed to assess the therapeutic efficacy of AL in the treatment of uncomplicated P. falciparum infection. METHODS: A 28 day onearm, prospective evaluation of the clinical and parasitological response to AL was conducted at Shecha Health Centre, Arba Minch town, Southern Ethiopia. Patients were treated with six-dose regimen of AL over three days and monitored for 28 days with clinical and laboratory assessments. Participant recruitment and outcome classification was done in accordance with the 2009 WHO methods for surveillance of anti-malarial drug efficacy guidelines. RESULTS: A total of 88 study participants were enrolled and 69 of them completed the study with adequate clinical and parasitological response. Two late parasitological failures were observed, of which one was classified as a recrudescence by polymerase chain reaction (PCR). The PCRcorrected cure rate was 98.6% (95% CI 92.3–100). AL demonstrated a rapid parasite and fever clearance with no parasitaemia on day 2 and febrile cases on day 3. Gametocyte clearance was complete by day three. No serious adverse events were reported during the 28 days follow-up. CONCLUSION: The study demonstrated high therapeutic efficacy and good safety profile of AL. This suggests the continuation of AL as the first-line drug for the treatment of uncomplicated P. falciparum malaria in Ethiopia. Periodic therapeutic efficacy studies and monitoring of markers of resistance are recommended for early detection of resistant parasites. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12936-022-04436-8. BioMed Central 2023-01-07 /pmc/articles/PMC9824982/ /pubmed/36611179 http://dx.doi.org/10.1186/s12936-022-04436-8 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Gubae, Kale
Mohammed, Hussein
Sime, Heven
Hailgiorgis, Henok
Mare, Anteneh Kassahun
Gidey, Bokretsion
Haile, Mebrahtom
Assefa, Gudissa
Bekele, Worku
Tasew, Geremew
Abay, Solomon Mequanente
Assefa, Ashenafi
Safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria at Shecha health centre, Arba Minch, Ethiopia
title Safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria at Shecha health centre, Arba Minch, Ethiopia
title_full Safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria at Shecha health centre, Arba Minch, Ethiopia
title_fullStr Safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria at Shecha health centre, Arba Minch, Ethiopia
title_full_unstemmed Safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria at Shecha health centre, Arba Minch, Ethiopia
title_short Safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria at Shecha health centre, Arba Minch, Ethiopia
title_sort safety and therapeutic efficacy of artemether-lumefantrine in the treatment of uncomplicated plasmodium falciparum malaria at shecha health centre, arba minch, ethiopia
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9824982/
https://www.ncbi.nlm.nih.gov/pubmed/36611179
http://dx.doi.org/10.1186/s12936-022-04436-8
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