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

ConditionMalaria
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age0-12
SponsorNovartis Pharmaceuticals

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

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators