Study to Assess Safety and Clinical Responses With Coartem® Baby Dispersible Tablets in Paediatric Patients Weighing 2 to <5 kg With Uncomplicated Malaria
brief summary
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.
detailed description
This is a multi-center, open-label, non-comparative study in neonates and infants (2 to \< 5 kg) diagnosed with acute uncomplicated malaria due to Plasmodium falciparum or mixed infections including P. falciparum malaria. The study is being performed in response to requests from Swissmedic and African National Regulatory Authorities following the approval of Coartem® Baby, to generate additional post-marketing data in this patient population.
official title
A Multi-centre, Open-label, Non-comparative Study to Assess Safety and Clinical Response With Coartem® Baby Dispersible Tablets in Paediatric Patients (≥ 2 to <5 kg) With Uncomplicated Malaria Due to Plasmodium Falciparum or Mixed Infections