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NOT YET RECRUITING
NCT07713602
PHASE4

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

View on ClinicalTrials.gov

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

DRUG

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.