Globally, infectious diseases such as pneumonia and sepsis are the leading cause of death and disability in children under five and are responsible for more than 3 million deaths a year. The situation is worsened by drug-resistant infections, as the limited number of treatments for children and babies are becoming less effective. More than 214,000 babies die each year from drug-resistant infections. Most of these deaths occur in low- and middle-countries.
Transforming care of babies with sepsis
Babies are a vulnerable population as their underdeveloped immune systems struggle to fight infections. Within hours, a baby with sepsis, an infection of the blood, can be in a life-threatening situation. This is complicated by drug resistance, with up to 40% of bacterial infections in babies resistant to standard treatments. Despite the huge numbers of babies affected by sepsis, our understanding of how to treat them is limited.
With St George’s University of London and the Paediatric Infectious Disease Network (Penta), GARDP has completed one of the largest ever studies on the care of babies with sepsis. This study, which has looked at over 3200 newborns in 19 sites across 11 countries, will provide evidence to fill knowledge gaps, help transform treatment and save lives. Preliminary results of the study were presented to sites involved in the study in October 2020, with final results submitted for publication by the end of 2020. Download the new In Focus on children’s antibiotics to learn more.
Treatments for children
Children are not small adults and their bodies react differently to antibiotics. It is critical to establish the correct dose for children and confirm safety and effectiveness. Even though children are disproportionately affected by drug resistance, there has been little effort to make antibiotics available for them. To address this lack of treatments, GARDP is working with partners to evaluate the dosage and safety of the antibiotic fosfomycin for use in children.
Information from this study, run in partnership with the KEMRI-Wellcome Trust Research Programme, Centre for Tropical Medicine and Global Health at the University of Oxford, Medical Research Council Clinical Trials Unit at University College London and St George’s University of London, will be published in 2020.
Evaluating safety and effectiveness
Although regulatory agencies require pharmaceutical companies to develop plans to evaluate new antibiotics for use in children, these are generally not started until after drugs are registered for use in adults. Many plans are delayed for years after licensing in adults, if they are developed at all. A recent study found that of 37 new antibiotics being developed in adults, just 2 were being studied in children. GARDP is working with partners to ensure the research and development of new and improved treatments includes evaluating them for use with babies and children.
Sustainable Development Goals
GARDP’s work to develop new and improved treatments for children is critical to achieving Sustainable Development Goal 3: Ensure healthy lives and promote well-being for all at all ages. Targets within this goal include ending the preventable deaths of newborns and children and ensuring access to effective medicines for everyone who needs them. With sepsis a leading cause of death in babies and children, the World Health Organization have called for urgent action on this infection to achieve SDG3.
In some countries, nearly half of antibiotics given to children are prescribed off-label, meaning children are prescribed drugs licensed for different infections or for use with different age groups. This places enormous pressure on doctors and a heavy reliance on specialist knowledge, which may be limited. It also contributes to the increase in drug resistance. GARDP is working with partners to improve guidance on treatments for children and babies.
Addressing neonatal sepsis, a neglected killer
It’s wonderful that for the first time on a broad scale people will be looking at what is happening to babies with sepsis. We know it’s the third leading cause of mortality in neonates, but we actually know verly little about what causes it and how to treat them. It often feels like we’re working in the dark. This will be an opportunity to to actually give our patients better care.
– Adrie Bekker, Associate Professor in Neonatology, University of Stellenbosch