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

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.

NCT Number	NCT07713602
Lead Sponsor	Novartis Pharmaceuticals
Conditions	Malaria
Enrollment	20 participants
Start Date	2027-06-18
Primary Completion	2028-05-04 (estimated)
Study Completion	2028-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-20