Ganaplacide (KAF156) plus lumefantrine solid dispersion formulation combination for uncomplicated Plasmodium falciparum malaria: an open-label, multicentre, parallel-group, randomised, controlled, phase 2 trial

Emergence of drug resistance demands novel antimalarial drugs with new mechanisms of action. We aimed to identify effective and well tolerated doses of ganaplacide plus lumefantrine solid dispersion formulation (SDF) in patients with uncomplicated Plasmodium falciparum malaria. This open-label, mult...

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Veröffentlicht in:	The Lancet infectious diseases 2023-09, Vol.23 (9), p.1051-1061
Hauptverfasser:	Ogutu, Bernhards, Yeka, Adoke, Kusemererwa, Sylvia, Thompson, Ricardo, Tinto, Halidou, Toure, Andre Offianan, Uthaisin, Chirapong, Verma, Amar, Kibuuka, Afizi, Lingani, Moussa, Lourenço, Carlos, Mombo-Ngoma, Ghyslain, Nduba, Videlis, N'Guessan, Tiacoh Landry, Nassa, Guétawendé Job Wilfried, Nyantaro, Mary, Tina, Lucas Otieno, Singh, Piyoosh K, El Gaaloul, Myriam, Marrast, Anne Claire, Chikoto, Havana, Csermak, Katalin, Demin, Ivan, Mehta, Dheeraj, Pathan, Rashidkhan, Risterucci, Celine, Su, Guoqin, Winnips, Cornelis, Kaguthi, Grace, Fofana, Bakary, Grobusch, Martin Peter
Format:	Artikel
Sprache:	eng
Schlagworte:	Adolescent Adolescents Adult Adults Antimalarial agents Antimalarials Antiparasitic agents Artemether Artemether - pharmacology Artemether - therapeutic use Artemisinins Child Children Dispersion Drug Combinations Drug resistance Electrocardiography Ethanolamines - pharmacology Ethanolamines - therapeutic use Fluorenes - pharmacology Fluorenes - therapeutic use Health services Humans Infections Infectious diseases Labels Lumefantrine - pharmacology Lumefantrine - therapeutic use Malaria Malaria - drug therapy Malaria, Falciparum - drug therapy Malaria, Falciparum - parasitology Parasites Patients Pharmacokinetics Plasmodium falciparum Randomization Statistical analysis Teenagers Treatment Outcome Vector-borne diseases
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Zusammenfassung:	Emergence of drug resistance demands novel antimalarial drugs with new mechanisms of action. We aimed to identify effective and well tolerated doses of ganaplacide plus lumefantrine solid dispersion formulation (SDF) in patients with uncomplicated Plasmodium falciparum malaria. This open-label, multicentre, parallel-group, randomised, controlled, phase 2 trial was conducted at 13 research clinics and general hospitals in ten African and Asian countries. Patients had microscopically-confirmed uncomplicated P falciparum malaria (>1000 and
ISSN:	1473-3099 1474-4457
DOI:	10.1016/S1473-3099(23)00209-8