About this trial
This study is being conducted to further evaluate the safety and clinical outcomes of Coartem® Baby (artemether/lumefantrine 5 mg/60 mg) in neonates and infants weighing ≥2 kg to \<5 kg with uncomplicated malaria due to Plasmodium falciparum or mixed infections under real-world conditions.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Coartem® Baby