Study to Assess Safety and Clinical Responses With Coartem® Baby Dispersible Tablets in Paediatric Patients Weighing 2 to <5 kg With Uncomplicated... | NCT07713602

NCT07713602

Overview

NCT ID: NCT07713602
Lead Sponsor: Novartis PharmaceuticalsINDUSTRY
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
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.
Conditions: Malaria
Interventions

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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

Central Contacts: Novartis PharmaceuticalsContact
novartis.email@novartis.com+41613241111