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Not Yet Recruiting NCT07713602

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

Conditions: Malaria

Sex: All
Ages: 0 Days – 12 Months
Healthy volunteers: No
Phase: PHASE4
Enrollment: 20
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 \

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07713602). StuddyBuddy aggregates publicly available trial information.