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Paediatric Primaquine

A series of individual patient data meta-analyses to investigate the safety, tolerability and efficacy of primaquine in paediatric patients with P. falciparum, P. vivax or P. ovale malaria.

These analyses will contribute evidence needed to inform recommendations on the use and optimal dosing of primaquine within the paediatric population.

Plasmodium falciparum & Paediatric Primaquine

1) Paediatric Single Low Dose Primaquine Efficacy Study Group  This study group aims to assess the efficacy of single low dose primaquine for transmission blocking of Plasmodium falciparum in young children (under 5 years old) with that of older children and adults to generate evidence that will inform improved dosing regimens with a new, clinically relevant, age-appropriate formulation

2) Paediatric Single Low Dose Primaquine Safety Study Group  This study group aims to assess the haematological and non-haematological safety and tolerability of single low dose primaquine for transmission blocking of Plasmodium falciparum in young children (under 5 years old) with that of older children and adults to generate evidence that will inform improved dosing regimens with a new, clinically relevant, age-appropriate formulation

Plasmodium vivax/ovale & Paediatric Primaquine

1) Paediatric Primaquine Gastro-Intestinal Tolerability Study Group This study group aims to assess the gastro-intestinal tolerability of primaquine in young children (under 5 years old) with that of older children and adults to generate evidence that will inform improved dosing regimens with a new, clinically relevant, age-appropriate formulation for radical cure of Plasmodium vivax/ovale malaria.

2) Paediatric Primaquine Adverse Event Study Group This study group aims to compare the incidence, severity and nature of adverse events in young children to those in older children and adults, that will inform improved dosing regimens with a new, clinically relevant, age-appropriate formulation.

3) Paediatric Primaquine Haematological Safety Study Group This study group aims to describe and compare changes in haemoglobin following primaquine in young children (under 5 years old) with that of older children and adults to generate evidence that will inform improved dosing regimens with a new, clinically relevant, age-appropriate formulation for radical cure of Plasmodium vivax/ovale malaria.

4) Paediatric Primaquine Efficacy Study Group This study group aims to assess the efficacy of primaquine in young children (under 5 years old) with that of older children and adults to generate evidence that will inform improved dosing regimens with a new, clinically relevant, age-appropriate formulation for radical cure of Plasmodium vivax/ovale malaria.

Pharmacokinetic-Pharmacodynamics of Paediatric Primaquine

Paediatric Primaquine Pk/Pd Study Group.  This study group aims to assess the pharmacokinetic (PK) and pharmacodynamic (PD) properties of primaquine in patients, with the specific aim of understanding the exposure associated with standard dosing in young children (under 5 years old). We will use nonlinear mixed-effects modelling to quantitatively characterise the PK/PD properties of primaquine and the influence of covariates (such as age and body weight). If needed, the developed PK/PD model will be used to optimise the dosing in young children for an improved dosing regimen. Further information will be available soon.

For more information and contact details of the Study Group Coordinators, please click on the links above.