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

NCT07713602 | Not Yet Recruiting Phase 4

• 1 other identifier: CCOA566B2405
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Keywords

Safety; clinical outcome; Coartem® Baby; infant; neonates; body weight ≥ 2 to <5 kg; uncomplicated malaria

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

  Number of participants with AEs and SAEs, including changes in vital signs and clinical laboratory measurements qualifying and reported as AEs.

  Up to Day 29

Secondary Outcomes (2)

• Proportion of patients with no malaria symptoms

  From Day 7 to Day 29

• Proportion of patients with positive parasitaemia

  From Day 7 to Day 29

Study Arms (1)

Coartem® Baby (5mg/60mg)

EXPERIMENTAL

Participants will receive Coartem® Baby at dose of 5mg/60mg twice per day for 3 days.

Drug: Coartem® Baby

Interventions

Coartem® Baby DRUG

Coartem® Baby 2.5mg/30mg oral dispersible tablets to be used at dose of 5mg/60 mg twice per day for 3 days.

Also known as: Artemether: Lumefantrine

Coartem® Baby (5mg/60mg)

Eligibility Criteria

• Age: 0 Days - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Malaria

Interventions

Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): June 18, 2027
• Primary Completion (Estimated): May 4, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share