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Study On Sepsis In Newborns And Antibiotic Prescribing Practices Launched

Study On Sepsis In Newborns And Antibiotic Prescribing Practices Launched

Over 80 researchers from 11 countries launched an observational study to understand sepsis in newborns and current antibiotic prescribing practices. This is part of the Global Antibiotic Research and Development Partnership’s (GARDP’s) broader programme to develop new and improved antibiotic treatments for newborns.

The observational study, led by the GARDP, is benefiting from US$2 million funding from Bill & Melinda Gates Foundation to support study sites in Bangladesh, India, Kenya, South Africa and Uganda.

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

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

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 hospitalized 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.

The observational study is being carried out in hospitals /neonatal units in Bangladesh, Brazil, China, Greece, India, Italy, Kenya, South Africa, Thailand, Vietnam and Uganda. The study has three sites in India (Lady Hardinge Medical College, New Delhi, KEM-Mumbai and JIPMER in Puducherry). The study focusses on collecting clinical information on babies with significant /clinical sepsis. 

The study will generate a robust evidence base on how neonatal sepsis is managed which can 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.

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

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