Paediatric populations (newborns, infants and children[1]) are particularly vulnerable to growing antimicrobial resistance (AMR). In Europe, drug-resistant infections are responsible for an estimated 2300 disability-adjusted-life-years (DALYs)[2] per 100,000 people every year- the majority in infants under 1-year-old.[3] The problem is expected to be higher still in many low-and-middle-income countries (LMICs). The AMR crisis is exacerbated by a lack of new antibiotics in development and paediatric patients are particularly affected. Treatments for neonates, infants and children need to be adapated to their specific needs, including the formulation and dosing of antibiotics. At present, if it happens at all, it takes around seven years for the evidence base for antibiotics used in adults to be adapted for paediatric patients.

GARDP’s paediatric antibiotic programme aims to expedite the development of new, improved and adapted antibiotics to treat serious bacterial infections in children of-all-ages. With a global focus, the programme aims to develop antibiotics for countries with a high burden of drug-resistance for use in hospitals and the community in both LMIC and high-income settings.

 

Objectives, by 2023

  • Up to two paediatric antibiotic projects in clinical development
  • One optimised paediatric antibiotic treatment ready for use in patients
  • A global network of experts and inter-connected trial sites with the capability to deliver antibiotic treatment options for priority paediatric and neonatal bacterial infections.

 

GARDP is developing a paediatric investigation plan[4] to facilitate initial registration of an antibiotic called polymyxin B in Europe, particularly in Italy and Greece, followed by other regions with a high burden of drug-resistance, including in Africa and Asia. GARDP has also started a collaboration with Novartis’ generic division, Sandoz, to accelerate the development and availability of antibiotic treatments for children in low and middle-income settings.

 

More information



[1] European Medicine Agency (EMA) definitions – newborns including neonates: up to 28-days, infants and toddler: up to 23-months, children 2-11 years-old, adolescents 12 years-old -16-18- years old, depending on region

[2] Disability-adjusted-life-years are a measurement of overall disease burden of years of healthy life lost through ill-health, disability or early death. More information

[3] Cassini, A. Attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the EU and the European Economic Area in 2015: a population-level modelling analysis” The Lancet Infectious Diseases 2018, doi: 10.1016/S1473-3099(18)30605-4

[4] A paediatric investigation plan is a development plan aimed at ensuring that the necessary data are obtained through studies in paediatric populations to support the authorisation of a medicine for use in children and infants. Source