Over 80 researchers from 11 countries met in New Delhi, India to kick off an observational study to understand sepsis in newborns and current antibiotic prescribing practices.

The new observational study is part of the Global Antibiotic Research and Development Partnership’s (GARDP’s) broader programme to develop new and improved antibiotic treatments for newborns.

Sepsis, the body’s response to infection, can be life-threatening and poses a particular threat to newborns as their immune systems are not fully developed. Increasing rates of bacteria resistant to existing treatments are reported globally, with hospitalised newborns and infants at high risk of developing drug-resistant hospital-acquired infections.

Newborns’ susceptibility to sepsis is further compounded by the challenges of diagnosing serious bacterial infections since symptoms and signs can be non-specific and difficult to detect.

While significant progress has been made in recent years to improve child health globally, including a 50% reduction in child mortality since 1990, the number of preventable deaths in newborns remains unacceptably high. Neonatal deaths now represent 44% of all deaths in children under the age of five. Of great concern, is the estimated 214,000 deaths in newborns attributable to drug-resistant infections.

Limited research on newborns has resulted in a lack of evidence about appropriate treatment of serious and drug-resistant infections in this vulnerable population.

GARDP’s observational study is responding to this global concern. The data generated from the study will inform GARPD’s ambition to develop and deliver new antibiotic treatments for newborns with drug-resistant bacterial infections.

The observational study is benefiting from US$2 million funding from Bill & Melinda Gates Foundation to support study sites in South Africa, Kenya, Uganda, Bangladesh and India. The study is focusing on collecting clinical information on babies with significant /clinical sepsis.

“We are grateful for Bill & Melinda Gates Foundation’s commitment. Antibacterial resistance is one of the main barriers to achieving the Sustainable Development Goal (STG) to reduce neonatal mortality,” said Director of GARDP, Dr Manica Balasegaram.

The study aims to generate an evidence base on how neonatal sepsis is managed, which can then be used as a basis for evaluating future interventions in neonates. Outcomes of interest will include mortality, antibiotic use and duration of antimicrobial therapy – there are currently few data on these parameters.

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