← Back to all trials
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
Source: ClinicalTrials.gov (NCT07713602). StuddyBuddy aggregates publicly available trial information.