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Multicenter, Open-label, Single-arm Study to Evaluate the PK, Safety, Tolerability and Efficacy of a New Artemether:Lumefantrine (2.5 mg:30 mg) Dispersible Tablet in the Treatment of Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria

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Trial Profile

Multicenter, Open-label, Single-arm Study to Evaluate the PK, Safety, Tolerability and Efficacy of a New Artemether:Lumefantrine (2.5 mg:30 mg) Dispersible Tablet in the Treatment of Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 23 May 2025

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At a glance

  • Drugs Artemether/lumefantrine (Primary)
  • Indications Falciparum malaria
  • Focus Pharmacokinetics; Registrational
  • Acronyms CALINA
  • Sponsors Novartis Pharmaceuticals

Most Recent Events

  • 03 Oct 2024 Status changed from active, no longer recruiting to discontinued as per the Sponsor's decision.
  • 18 Jul 2024 According to Novartis media release, data from this trial presented at the Multilateral Initiative on Malaria Pan-African Malaria Conference 2024.
  • 24 Apr 2024 Primary endpoint (Artemether Cmax) has been met, according to a Medicines for Malaria Venture Media Release.

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