Study to Assess Safety and Clinical Responses With Coartem® Baby Dispersible Tablets in Paediatric Patients Weighing 2 to <5 kg With Uncomplicated Malaria

This is a multi-center, open-label, non-comparative study in neonates and infants (2 to < 5 kg) diagnosed with acute uncomplicated malaria due to Plasmodium falciparum or mixed infections including P. falciparum malaria. The study is being performed in response to requests from Swissmedic and African National Regulatory Authorities following the approval of Coartem® Baby, to generate additional post-marketing data in this patient population.

Key Inclusion Criteria:

• Male or female neonates/infants
• Body weight ≥ 2 kg to < 5kg
• Confirmed diagnosis of uncomplicated infections due to Plasmodium falciparum or mixed infections including P. falciparum malaria by RDT or microscopy.
• Eligible to receive Coartem® Baby dispersible tablets as per approved label

Key Exclusion Criteria:

Participants with Coartem® Baby contraindications as per approved label.

• Known hypersensitivity to artemether, lumefantrine or to any of the excipients of Coartem® Baby.
• Patients with severe malaria according to WHO definition (See Appendix 3).
• Patients with a family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as patients with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
• Patients taking drugs that are known to prolong the QTc interval
• Any additional contraindications as per the approved label in the country