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.
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
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
Single group
Coartem® Baby
DrugCoartem® Baby 2.5mg/30mg oral dispersible tablets to be used at dose of 5mg/60 mg twice per day for 3 days.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Number of participants with AEs and SAEs, including changes in vital signs and clinical laboratory measurements qualifying and reported as AEs.
Proportion of patients with no malaria symptoms
Clinical response is defined as - No malaria symptoms such as (and not limited to) fever, chills, poor feeding, respiratory distress, irritability or restlessness as evaluated by the treating physician.
Proportion of patients with positive parasitaemia
Positive parasitaemia is defined as at least ≥100 parasites/µl by microscopy during follow up visits in presence of recurrence/persistence/worsening of malaria symptoms.
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This trial is not recruiting at the moment. You can still explore other options:
