Abstract
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. 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. 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...Continue Reading
References
Jan 6, 1996·Lancet·P RingwaldL Basco
Jun 13, 1998·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·P RingwaldL K Basco
May 29, 1999·The American Journal of Tropical Medicine and Hygiene·R PriceF Nosten
Feb 19, 2000·Antimicrobial Agents and Chemotherapy·F EzzetN J White
Aug 13, 2008·The Journal of Infectious Diseases·Michael RamharterPeter G Kremsner
Feb 2, 2010·The Lancet Infectious Diseases·Florian KurthMichael Ramharter
Feb 5, 2010·The Lancet Infectious Diseases·Stephen J RogersonSteven R Meshnick
Apr 27, 2010·Lancet·Francois Henri Nosten
Apr 27, 2010·Lancet·Antoinette K TshefuUNKNOWN Pyronaridine-artesunate Study Team
Jan 27, 2011·PloS One·Yi PoravuthLawrence Fleckenstein
Oct 12, 2011·Current Opinion in Infectious Diseases·Florian KurthMichael Ramharter
Apr 6, 2012·The New England Journal of Medicine·Ronnatrai RueangweerayutUNKNOWN Pyronaridine–Artesunate Study Team
Aug 11, 2012·Malaria Journal·Simon L CroftHan-Jong Rim
Nov 2, 2012·Malaria Journal·Kassoum KayentaoLawrence Fleckenstein
Feb 26, 2013·Malaria Journal·Stephan DuparcLawrence Fleckenstein
Jul 31, 2014·The New England Journal of Medicine·Elizabeth A AshleyUNKNOWN Tracking Resistance to Artemisinin Collaboration (TRAC)
Apr 25, 2015·Malaria Journal·Socrates Litsios
Nov 26, 2015·The Lancet Infectious Diseases·Issaka SagaraAbdoulaye A Djimdé
Dec 1, 2015·Scientific Reports·Mallika ImwongArjen M Dondorp
Mar 2, 2016·Antimicrobial Agents and Chemotherapy·Rithea LeangPascal Ringwald
Jun 24, 2016·Microbiology Spectrum·Rick M Fairhurst, Arjen M Dondorp
Citations
Jan 9, 2019·The Cochrane Database of Systematic Reviews·Joseph Pryce, Paul Hine
Jan 4, 2019·Antimicrobial Agents and Chemotherapy·Rithea LeangBenoit Witkowski
Jul 13, 2019·Malaria Journal·Marian WarsamePascal Ringwald
Jun 6, 2018·Malaria Journal·Johanna M RothPètra F Mens
Jun 27, 2019·Malaria Journal·Benjamin AbuakuKwadwo Koram
Nov 28, 2020·Pharmacogenomics·Adebanjo J AdegbolaOluseye O Bolaji
Dec 9, 2020·The Cochrane Database of Systematic Reviews·Sabine BélardFlorian Kurth
Nov 5, 2020·Journal of Parasitology Research·Awoke DerbieTamrat Abebe
Dec 7, 2020·Biopolymers·Christian Bailly
Jun 16, 2021·PLoS Medicine·Gaston Tona LuteteUNKNOWN CANTAM study group
Jun 24, 2021·Malaria Journal·Matilde Riloha RivasPascal Ringwald
May 14, 2021·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Edgard D DabiraJane Achan
Dec 26, 2021·Malaria Journal·Chris EbongAdoke Yeka