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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
Sponsor: Novartis Pharmaceuticals
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.
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
Key Details
Gender
All
Age Range
0 Days - 12 Months
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2027-06-18
Completion Date
2028-05-31
Last Updated
2026-07-20
Healthy Volunteers
No
Conditions
Interventions
Coartem® Baby
Coartem® Baby 2.5mg/30mg oral dispersible tablets to be used at dose of 5mg/60 mg twice per day for 3 days.