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

NCT07713602

Not Yet RecruitingPhase 4

Sponsor: Novartis Pharmaceuticals

Conditions: Malaria

Interventions: Coartem® Baby

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 overview

Sex: ALL

Age: 0 Days to 12 Months

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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