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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Published in:The Lancet infectious diseases 2023-09, Vol.23 (9), p.1051-1061
Main Authors: 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: Article
Language:English
Subjects:
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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Description
Summary: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