Pharmacy and Poisons Board
Protocol No: ECCT/20/12/03 Date of Protocol: 02-12-2019
Study Title:

A 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.

Study number: CCOA566B2307
Study Objectives:

Primary objective

  • To assess the key PK parameter of artemether in infants and neonates < 5 kg body weight dosed with the new formulation of artemether-lumefantrine

    dispersible tablet

Secondary objectives

  • To assess other key PK parameters of artemether, DHA and lumefantrine in infants and neonates <5 kg body weight dosed with the new formulation of artemether-lumefantrine dispersible tablet

  • To evaluate the safety and tolerability of the new formulation of artemether-lumefantrine dispersible tablet in infants and neonates <5 kg body weight with acute uncomplicated P. falciparum malaria 

  • To determine the efficacy of the new formulation of artemether-lumefantrine dispersible tablet for treatment of acute uncomplicated P. falciparum malaria in infants and neonates <5 kg body weight

Exploratory objectives

  • To assess model-derived exposure metrics based on population PK modeling of artemether, DHA and lumefantrine in infants and neonates <5 kg body weight dosed with the new formulation of artemether-lumefantrine dispersible tablet

  • To further evaluate safety of the new formulation of artemether-lumefantrine dispersible tablet in infants and neonates <5 kg body weight

  • To explore the effect of the new formulation of artemether-lumefantrine dispersible tablet on gametocytes

 
Laymans Summary:

 This Phase II/III study aims to evaluate Pharmacokinetics, safety, tolerability  and efficacy of a new artemether-lumefantrine dispersible tablet in infants and neonates less than 5 Kg body weight with acute uncomplicated Plasmodium falciparum malaria. This will be a multicenter, open-label, single-arm, adaptive design with dose adaptation (de-escalation and escalation_ study in infants and neonates with P. falciparum malaria.
Abstract of Study:

This study aims to evaluate PK, safety, tolerability and efficacy of a new formulation of artemether-lumefantrine dispersible tablets in neonates and infants with acute uncomplicated Plasmodium falciparum malaria.

Malaria is a disease that has a much higher prevalence and severity in infants and children. Although relatively infrequent as compared to the number of cases in infants and children greater or equal to 5kg, confirmed malaria in neonates and infants less than 5kg does exist in certain endemic countries and calls for evaluation of appropriate treatment. It is still significant unmet medical need as there are no approved treatments for this vulnerable group of patients