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Published: 27 January 2023

Two St George’s researchers are among a group of global experts calling for an accelerated, coordinated approach to the development of antibiotics for newborn babies to reduce deaths and tackle rising rates of antibiotic resistance.

Dr Julia Bielicki and Professor Mike Sharland of the Centre for Neonatal and Paediatric Infection are part of the group, which published a paper in the December 2022 Bulletin of the World Health Organization. The group also contained experts from the not-for-profit organisation Global Antibiotic Research & Development Partnership (GARDP) and Penta - Child Health Research, an international independent scientific network dedicated to child health. Neonatologists in India and South Africa also contributed to the paper.

According to recent estimates, around 2.3 million newborns die of severe bacterial infections each year. Newborns are particularly vulnerable to antibiotic resistance, with commonly used antibiotics becoming increasingly ineffective in newborn babies.

In newborns looked after in some settings over the last decade, AMR has worsened to the point where around 50-70% of common pathogens exhibit a high degree of resistance to available first and second-line antibiotics. And despite progress in avoiding deaths in children under five from preventable disease, severe bacterial infections remain a challenge to be tackled, especially for young infants.

The paper calls for urgent action to ensure that newborns have access to appropriate antibiotics. Despite an increase in the proportion of newborn deaths linked to antimicrobial resistance, very few antibiotics have been tested for their effectiveness in treating neonatal sepsis, where the body’s response to infection overwhelming and begins to damage itself.

Conducting research in newborns is ethically and logistically challenging. Though 40 antibiotics have been approved for adults since 2000, just four have available dosing information for newborns. And while there are currently 43 adult antibiotic clinical trials recruiting patients, just six trials are recruiting neonates.

“There is an urgent need to identify high priority antibiotics to understand which ones work best and safely in children, and then make them available where they are needed,” said Prof Sharland, who is also a member of the Antimicrobial Resistance Programme at Penta - Child Health Research.

The best way to do this would be through global coordination, the paper says. It calls for a collaborative global antibiotic development and access network specifically targeting newborns, which would be more effective than independent studies. Such a network could identify which antibacterials to prioritise for further study in newborns, as well as standardising regulatory criteria for approval.

Coordination and harmonisation of efforts could also lead to an agreement on study designs addressing the evidence threshold for regulatory approval and clinical utility at the same time.

The paper’s authors have already begun to collaborate. They recently worked together to assess routine treatment of neonatal sepsis in 3,200 babies in 19 hospitals across 11 countries. And they will soon begin a clinical trial comparing different treatment regimens to overcome resistance to current sepsis treatments. Beginning in South Africa before being expanded to other countries, it will particularly focus on low- and middle-income countries where pathogens resistant to multiple antibiotics are more common.

“By achieving global consensus, we can streamline the process of antibiotic development, allow for faster access to antibiotics, and reduce the burden of AMR on the vulnerable neonatal population,” said Manica Balasegaram, Executive Director of GARDP.

“We need to move fast to develop guidelines and protocols on the use of antibiotics, as well as develop new antibiotics,” said Sithembiso Velaphi, Head of Paediatrics at the Chris Hani Baragwanath Academic hospital in Soweto, South Africa. “We have the opportunity to prevent more unnecessary deaths of babies from these severe infections by intervening, quickly, equitably, and safely. It is also critical that all efforts must be made to prevent these infections through ensuring that all healthcare facilities and providers adhere to infection prevention and control protocols.”

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