Overview

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

Status:
Recruiting

Trial end date:
2023-12-02

Target enrollment:

Participant gender:

Summary

This study aims 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.

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

Novartis Pharmaceuticals

Collaborators:

European and Developing Countries Clinical Trials Partnership (EDCTP)
Groupe de Recherche Action en Santé (GRAS), Ouagadougou, Burkina Faso
Institut de Recherche en sciences de la Santé - Unité de Recherche Clinique de Nanoro (IRSS-URCN), Burkina Faso
Medicines for Malaria Venture (MMV), Switzerland

Treatments:

Artemether
Lumefantrine