Pyronaridine-artesunate granules versus artemether-lumefantrine crushed tablets in children with Plasmodium falciparum malaria: a randomized controlled trial
Abstract Background Children are most vulnerable to malaria. A pyronaridine-artesunate pediatric granule formulation is being developed for the treatment of uncomplicated Plasmodium falciparum malaria. Methods This phase III, multi-center, comparative, open-label, parallel-group, controlled clinical...
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Online Access: | https://doi.org/10.1186/1475-2875-11-364 https://doaj.org/article/29d6c9e1fbec48a9a85d7d9f7b5276d8 |
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ftdoajarticles:oai:doaj.org/article:29d6c9e1fbec48a9a85d7d9f7b5276d8 2023-05-15T15:16:10+02:00 Pyronaridine-artesunate granules versus artemether-lumefantrine crushed tablets in children with Plasmodium falciparum malaria: a randomized controlled trial Kayentao Kassoum Doumbo Ogobara K Pénali Louis K Offianan André T Bhatt Kirana M Kimani Joshua Tshefu Antoinette K Kokolomami Jack HT Ramharter Michael de Salazar Pablo Martinez Tiono Alfred B Ouédraogo Alphonse Bustos Maria Dorina G Quicho Frederick Borghini-Fuhrer Isabelle Duparc Stephan Shin Chang-Sik Fleckenstein Lawrence 2012-10-01T00:00:00Z https://doi.org/10.1186/1475-2875-11-364 https://doaj.org/article/29d6c9e1fbec48a9a85d7d9f7b5276d8 EN eng BMC http://www.malariajournal.com/content/11/1/364 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-11-364 1475-2875 https://doaj.org/article/29d6c9e1fbec48a9a85d7d9f7b5276d8 Malaria Journal, Vol 11, Iss 1, p 364 (2012) Pyronaridine-artesunate Artemether-lumefantrine Malaria Plasmodium falciparum Pediatric Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 article 2012 ftdoajarticles https://doi.org/10.1186/1475-2875-11-364 2022-12-31T08:32:21Z Abstract Background Children are most vulnerable to malaria. A pyronaridine-artesunate pediatric granule formulation is being developed for the treatment of uncomplicated Plasmodium falciparum malaria. Methods This phase III, multi-center, comparative, open-label, parallel-group, controlled clinical trial included patients aged ≤12 years, bodyweight ≥5 to <25 kg, with a reported history of fever at inclusion or in the previous 24 h and microscopically-confirmed uncomplicated P. falciparum malaria. Patients were randomized (2:1) to pyronaridine-artesunate granules (60/20 mg) once daily or artemether-lumefantrine crushed tablets (20/120 mg) twice daily, both dosed by bodyweight, orally (liquid suspension) for three days. Results Of 535 patients randomized, 355 received pyronaridine-artesunate and 180 received artemether-lumefantrine. Day-28 adequate clinical and parasitological response (ACPR), corrected for re-infection using polymerase chain reaction (PCR) genotyping (per-protocol population) was 97.1% (329/339; 95% CI 94.6, 98.6) for pyronaridine-artesunate; 98.8% (165/167; 95% CI 95.7, 99.9) for artemether-lumefantrine. The primary endpoint was achieved: pyronaridine-artesunate PCR-corrected day-28 ACPR was statistically significantly >90% ( P < .0001). Pyronaridine-artesunate was non-inferior to artemether-lumefantrine: treatment difference -1.8% (95% CI -4.3 to 1.6). The incidence of drug-related adverse events was 37.2% (132/355) with pyronaridine-artesunate, 44.4% (80/180) with artemether-lumefantrine. Clinical biochemistry results showed similar mean changes versus baseline in the two treatment groups. From day 3 until study completion, one patient in each treatment group had peak alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN) and peak total bilirubin >2xULN (i.e. within the Hy’s law definition). Conclusions The pyronaridine-artesunate pediatric granule formulation was efficacious and was non-inferior to artemether-lumefantrine. The adverse event profile was similar ... Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Malaria Journal 11 1 364 |
institution |
Open Polar |
collection |
Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Pyronaridine-artesunate Artemether-lumefantrine Malaria Plasmodium falciparum Pediatric Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
spellingShingle |
Pyronaridine-artesunate Artemether-lumefantrine Malaria Plasmodium falciparum Pediatric Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 Kayentao Kassoum Doumbo Ogobara K Pénali Louis K Offianan André T Bhatt Kirana M Kimani Joshua Tshefu Antoinette K Kokolomami Jack HT Ramharter Michael de Salazar Pablo Martinez Tiono Alfred B Ouédraogo Alphonse Bustos Maria Dorina G Quicho Frederick Borghini-Fuhrer Isabelle Duparc Stephan Shin Chang-Sik Fleckenstein Lawrence Pyronaridine-artesunate granules versus artemether-lumefantrine crushed tablets in children with Plasmodium falciparum malaria: a randomized controlled trial |
topic_facet |
Pyronaridine-artesunate Artemether-lumefantrine Malaria Plasmodium falciparum Pediatric Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
description |
Abstract Background Children are most vulnerable to malaria. A pyronaridine-artesunate pediatric granule formulation is being developed for the treatment of uncomplicated Plasmodium falciparum malaria. Methods This phase III, multi-center, comparative, open-label, parallel-group, controlled clinical trial included patients aged ≤12 years, bodyweight ≥5 to <25 kg, with a reported history of fever at inclusion or in the previous 24 h and microscopically-confirmed uncomplicated P. falciparum malaria. Patients were randomized (2:1) to pyronaridine-artesunate granules (60/20 mg) once daily or artemether-lumefantrine crushed tablets (20/120 mg) twice daily, both dosed by bodyweight, orally (liquid suspension) for three days. Results Of 535 patients randomized, 355 received pyronaridine-artesunate and 180 received artemether-lumefantrine. Day-28 adequate clinical and parasitological response (ACPR), corrected for re-infection using polymerase chain reaction (PCR) genotyping (per-protocol population) was 97.1% (329/339; 95% CI 94.6, 98.6) for pyronaridine-artesunate; 98.8% (165/167; 95% CI 95.7, 99.9) for artemether-lumefantrine. The primary endpoint was achieved: pyronaridine-artesunate PCR-corrected day-28 ACPR was statistically significantly >90% ( P < .0001). Pyronaridine-artesunate was non-inferior to artemether-lumefantrine: treatment difference -1.8% (95% CI -4.3 to 1.6). The incidence of drug-related adverse events was 37.2% (132/355) with pyronaridine-artesunate, 44.4% (80/180) with artemether-lumefantrine. Clinical biochemistry results showed similar mean changes versus baseline in the two treatment groups. From day 3 until study completion, one patient in each treatment group had peak alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN) and peak total bilirubin >2xULN (i.e. within the Hy’s law definition). Conclusions The pyronaridine-artesunate pediatric granule formulation was efficacious and was non-inferior to artemether-lumefantrine. The adverse event profile was similar ... |
format |
Article in Journal/Newspaper |
author |
Kayentao Kassoum Doumbo Ogobara K Pénali Louis K Offianan André T Bhatt Kirana M Kimani Joshua Tshefu Antoinette K Kokolomami Jack HT Ramharter Michael de Salazar Pablo Martinez Tiono Alfred B Ouédraogo Alphonse Bustos Maria Dorina G Quicho Frederick Borghini-Fuhrer Isabelle Duparc Stephan Shin Chang-Sik Fleckenstein Lawrence |
author_facet |
Kayentao Kassoum Doumbo Ogobara K Pénali Louis K Offianan André T Bhatt Kirana M Kimani Joshua Tshefu Antoinette K Kokolomami Jack HT Ramharter Michael de Salazar Pablo Martinez Tiono Alfred B Ouédraogo Alphonse Bustos Maria Dorina G Quicho Frederick Borghini-Fuhrer Isabelle Duparc Stephan Shin Chang-Sik Fleckenstein Lawrence |
author_sort |
Kayentao Kassoum |
title |
Pyronaridine-artesunate granules versus artemether-lumefantrine crushed tablets in children with Plasmodium falciparum malaria: a randomized controlled trial |
title_short |
Pyronaridine-artesunate granules versus artemether-lumefantrine crushed tablets in children with Plasmodium falciparum malaria: a randomized controlled trial |
title_full |
Pyronaridine-artesunate granules versus artemether-lumefantrine crushed tablets in children with Plasmodium falciparum malaria: a randomized controlled trial |
title_fullStr |
Pyronaridine-artesunate granules versus artemether-lumefantrine crushed tablets in children with Plasmodium falciparum malaria: a randomized controlled trial |
title_full_unstemmed |
Pyronaridine-artesunate granules versus artemether-lumefantrine crushed tablets in children with Plasmodium falciparum malaria: a randomized controlled trial |
title_sort |
pyronaridine-artesunate granules versus artemether-lumefantrine crushed tablets in children with plasmodium falciparum malaria: a randomized controlled trial |
publisher |
BMC |
publishDate |
2012 |
url |
https://doi.org/10.1186/1475-2875-11-364 https://doaj.org/article/29d6c9e1fbec48a9a85d7d9f7b5276d8 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Malaria Journal, Vol 11, Iss 1, p 364 (2012) |
op_relation |
http://www.malariajournal.com/content/11/1/364 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-11-364 1475-2875 https://doaj.org/article/29d6c9e1fbec48a9a85d7d9f7b5276d8 |
op_doi |
https://doi.org/10.1186/1475-2875-11-364 |
container_title |
Malaria Journal |
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11 |
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1 |
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364 |
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1766346470299009024 |