Pyronaridine–artesunate and artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a randomized controlled non-inferiority trial
Abstract Background Pyronaridine–artesunate is a novel artemisinin-based combination therapy. The efficacy and safety of pyronaridine–artesunate were compared with artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in children. Methods This phase III open-label...
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ftdoajarticles:oai:doaj.org/article:9976c10dddd745d398c82f16c86b06da 2023-05-15T15:15:27+02:00 Pyronaridine–artesunate and artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a randomized controlled non-inferiority trial Johanna M. Roth Patrick Sawa Nicodemus Makio George Omweri Victor Osoti Selpha Okach Felix Choy Henk D. F. H. Schallig Pètra Mens 2018-05-01T00:00:00Z https://doi.org/10.1186/s12936-018-2340-3 https://doaj.org/article/9976c10dddd745d398c82f16c86b06da EN eng BMC http://link.springer.com/article/10.1186/s12936-018-2340-3 https://doaj.org/toc/1475-2875 doi:10.1186/s12936-018-2340-3 1475-2875 https://doaj.org/article/9976c10dddd745d398c82f16c86b06da Malaria Journal, Vol 17, Iss 1, Pp 1-12 (2018) Plasmodium falciparum Malaria Paediatric Pyronaridine–artesunate Artemether–lumefantrine Kenya Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 article 2018 ftdoajarticles https://doi.org/10.1186/s12936-018-2340-3 2022-12-31T16:27:14Z Abstract Background Pyronaridine–artesunate is a novel artemisinin-based combination therapy. The efficacy and safety of pyronaridine–artesunate were compared with artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in children. Methods This phase III open-label randomized controlled non-inferiority trial was conducted in Western Kenya. Children aged 6 months to ≤ 12 years with a bodyweight > 5 kg and microscopically confirmed P. falciparum malaria were randomly assigned in a 1:1 ratio to orally receive pyronaridine–artesunate or artemether–lumefantrine, dosed according to bodyweight, for 3 days. Results Of 197 participants, 101 received pyronaridine–artesunate and 96 received artemether–lumefantrine. The day-28 adequate clinical and parasitological response in the per-protocol population, PCR-corrected for reinfections, was 98.9% (93/94, 95% CI 94.2–99.8) for pyronaridine–artesunate and 96.4% (81/84, 95% CI 90.0–98.8) for artemether–lumefantrine. Pyronaridine–artesunate was found to be non-inferior to artemether–lumefantrine: the treatment difference was 2.5% (95% CI − 2.8 to 9.0). Adverse events occurred in 41.6% (42/101) and 34.4% (33/96) of patients in the pyronaridine–artesunate group and the artemether–lumefantrine group, respectively. No participants were found to have alanine or aspartate aminotransferase levels > 3 times the upper limit of normal. Conclusions Pyronaridine–artesunate was well tolerated, efficacious and non-inferior to artemether–lumefantrine for the treatment of uncomplicated P. falciparum malaria in Kenyan children. Results are in line with previous reports and inclusion of pyronaridine–artesunate in paediatric malaria treatment programmes should be considered. This study is registered at clinicaltrials.gov under NCT02411994. Registration date: 8 April 2015. https://clinicaltrials.gov/ct2/show/NCT02411994?term=pyronaridine–artesunate&cond=Malaria&cntry=KE&rank=1 Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Malaria Journal 17 1 |
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Directory of Open Access Journals: DOAJ Articles |
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Plasmodium falciparum Malaria Paediatric Pyronaridine–artesunate Artemether–lumefantrine Kenya Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
spellingShingle |
Plasmodium falciparum Malaria Paediatric Pyronaridine–artesunate Artemether–lumefantrine Kenya Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 Johanna M. Roth Patrick Sawa Nicodemus Makio George Omweri Victor Osoti Selpha Okach Felix Choy Henk D. F. H. Schallig Pètra Mens Pyronaridine–artesunate and artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a randomized controlled non-inferiority trial |
topic_facet |
Plasmodium falciparum Malaria Paediatric Pyronaridine–artesunate Artemether–lumefantrine Kenya Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
description |
Abstract Background Pyronaridine–artesunate is a novel artemisinin-based combination therapy. The efficacy and safety of pyronaridine–artesunate were compared with artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in children. Methods This phase III open-label randomized controlled non-inferiority trial was conducted in Western Kenya. Children aged 6 months to ≤ 12 years with a bodyweight > 5 kg and microscopically confirmed P. falciparum malaria were randomly assigned in a 1:1 ratio to orally receive pyronaridine–artesunate or artemether–lumefantrine, dosed according to bodyweight, for 3 days. Results Of 197 participants, 101 received pyronaridine–artesunate and 96 received artemether–lumefantrine. The day-28 adequate clinical and parasitological response in the per-protocol population, PCR-corrected for reinfections, was 98.9% (93/94, 95% CI 94.2–99.8) for pyronaridine–artesunate and 96.4% (81/84, 95% CI 90.0–98.8) for artemether–lumefantrine. Pyronaridine–artesunate was found to be non-inferior to artemether–lumefantrine: the treatment difference was 2.5% (95% CI − 2.8 to 9.0). Adverse events occurred in 41.6% (42/101) and 34.4% (33/96) of patients in the pyronaridine–artesunate group and the artemether–lumefantrine group, respectively. No participants were found to have alanine or aspartate aminotransferase levels > 3 times the upper limit of normal. Conclusions Pyronaridine–artesunate was well tolerated, efficacious and non-inferior to artemether–lumefantrine for the treatment of uncomplicated P. falciparum malaria in Kenyan children. Results are in line with previous reports and inclusion of pyronaridine–artesunate in paediatric malaria treatment programmes should be considered. This study is registered at clinicaltrials.gov under NCT02411994. Registration date: 8 April 2015. https://clinicaltrials.gov/ct2/show/NCT02411994?term=pyronaridine–artesunate&cond=Malaria&cntry=KE&rank=1 |
format |
Article in Journal/Newspaper |
author |
Johanna M. Roth Patrick Sawa Nicodemus Makio George Omweri Victor Osoti Selpha Okach Felix Choy Henk D. F. H. Schallig Pètra Mens |
author_facet |
Johanna M. Roth Patrick Sawa Nicodemus Makio George Omweri Victor Osoti Selpha Okach Felix Choy Henk D. F. H. Schallig Pètra Mens |
author_sort |
Johanna M. Roth |
title |
Pyronaridine–artesunate and artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a randomized controlled non-inferiority trial |
title_short |
Pyronaridine–artesunate and artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a randomized controlled non-inferiority trial |
title_full |
Pyronaridine–artesunate and artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a randomized controlled non-inferiority trial |
title_fullStr |
Pyronaridine–artesunate and artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a randomized controlled non-inferiority trial |
title_full_unstemmed |
Pyronaridine–artesunate and artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a randomized controlled non-inferiority trial |
title_sort |
pyronaridine–artesunate and artemether–lumefantrine for the treatment of uncomplicated plasmodium falciparum malaria in kenyan children: a randomized controlled non-inferiority trial |
publisher |
BMC |
publishDate |
2018 |
url |
https://doi.org/10.1186/s12936-018-2340-3 https://doaj.org/article/9976c10dddd745d398c82f16c86b06da |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Malaria Journal, Vol 17, Iss 1, Pp 1-12 (2018) |
op_relation |
http://link.springer.com/article/10.1186/s12936-018-2340-3 https://doaj.org/toc/1475-2875 doi:10.1186/s12936-018-2340-3 1475-2875 https://doaj.org/article/9976c10dddd745d398c82f16c86b06da |
op_doi |
https://doi.org/10.1186/s12936-018-2340-3 |
container_title |
Malaria Journal |
container_volume |
17 |
container_issue |
1 |
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1766345817266847744 |