NCT04300309

Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria

Multicenter, Open-label, Single-arm Study to Evaluate the PK, Safety, Tolerability and Efficacy of a New Artemether:Lumefantrine (2.5 mg:30 mg) Dispersible Tablet in the Treatment of Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 365 Days
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate PK, safety, tolerability and efficacy of a new formulation of artemether-lumefantrine dispersible tablet in neonates and infants \<5 kg body weight with acute uncomplicated Plasmodium falciparum malaria.

Detailed description

This was a multicenter, open-label, single-arm, adaptive design with dose adaptation (deescalation or escalation) study in infants and neonates \<5 kg body weight with P. falciparum malaria. There were two sequential and age-descending cohorts of participants, all \<5 kg: Cohort 1 of infants \>28 days of age, and Cohort 2 of neonates ≤ 28 days of age.

Conditions

• Plasmodium Falciparum Malaria

Interventions

Type	Name	Description
DRUG	artemether:lumefantrine (2.5 mg:30 mg)	Two oral dispersible tablets twice daily for three consecutive days. Each tablet contained artemether-lumefantrine 2.5 mg:30 mg.

Timeline

• Start date: 2020-12-21
• Primary completion: 2023-07-02
• Completion: 2024-05-10
• First posted: 2020-03-09
• Last updated: 2026-01-13
• Results posted: 2024-10-03

Locations

3 sites across 2 countries: Burkina Faso, Democratic Republic of the Congo