Ganaplacide plus lumefantrine solid dispersion formulation for children with uncomplicated Plasmodium falciparum malaria (KALUMI): an open-label, multicentre, randomised, controlled, adaptive, phase 2, non-inferiority trial.

Ganaplacide 400 mg plus lumefantrine SDF 480 mg once daily for 3 days with a light meal is non-inferior to artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria, with day-29 response rates of 99% vs 99%.

• Why it matters: Food-dependent absorption and pediatric dosing uncertainty limit confidence in using ganaplacide–lumefantrine SDF in routine treatment, especially versus the standard artemether-lumefantrine regimen.
• What they did: In an open-label, multicentre, randomised, controlled, adaptive phase 2 trial in Burkina Faso, Mali, Côte d’Ivoire, Gabon, and DR Congo, food effects were measured in run-in cohorts and non-inferiority was tested in 220 children (day-29 PCR-corrected response; margin 10%).
• The result: Lumefantrine exposure showed a significant fed–fasted effect (mean ratios 1·48 to 2·87), leading to selection of the 480 mg once-daily regimen; day-29 treatment difference was -0·0% (95% CI -2·9 to 2·8), with vomiting 29% vs 11% and hypokalaemia 25% vs 15%.

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