Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria

Phase 2/3 Terminated 28 enrolled Novartis Pharmaceuticals European and Developing Countries Clinical Trials Partnership (EDCTP) · collab Groupe de Recherche Action en Sante · collab Institut de Recherche en Sciences de la Sante, Burkina Faso · collab Medicines for Malaria Venture · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study was to evaluate PK, safety, tolerability and efficacy of a new formulation of artemether-lumefantrine dispersible tablet in neonates and infants \<5 kg body weight with acute uncomplicated Plasmodium falciparum malaria.

Timeline

Start: 2020-12-21
Primary completion: 2023-07-02
Completion: 2024-05-10

Outcome

Met primary endpoint

Stopped (Business): “Sponsor decision”

paper therefore, Cmax was comparable to that in historical data, meeting the primary endpoint. PMID 41199347 ↗

Publications

Wounounou G, Tiono AB, Ogutu B, Manyando C, Sagara I, Schneitter S, Bassat Q, Gaaloul ME, Marrast AC, Demin I, Winnips C, Risterucci C, Hugot S, Hofstetter G, Qian Z, Su G, Zhang J, Renner KC, Cousin M, Venishetty VK, Sayyed S, Gandhi P, Kabore B; CALINA study group. Pharmacokinetics, safety and efficacy of an optimized dose of artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in neonates and infants of less than 5 kg body weight: a multicentre, open-label, single-arm phase 2/3 study (CALINA). Trop Med Health. 2025 Nov 6;53(1):151. doi: 10.1186/s41182-025-00828-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Artemether	Small molecule	5 mg	Oral
Subject	lumefantrine	Small molecule	60 mg	Oral