The Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) has achieved a significant milestone by becoming the first centre in India to enrol a newborn in the NeoSep1 international clinical trial. This multicentre study is coordinated by the Global Antibiotic Research and Development Partnership (GARDP), a not-for-profit organisation dedicated to developing and ensuring equitable access to treatments for drug-resistant infections. Over the next three years, the trial aims to enrol nearly 3,000 newborns across hospitals in Asia and Africa to evaluate safe, effective, and affordable antibiotic combinations for neonatal sepsis.

Dr. Nishad Plakkal, Professor and Head, Department of Neonatology, JIPMER, is the Principal Investigator for the study at JIPMER and also represents all Asia-Pacific trial sites on the NeoSep1 Trial Steering Committee. Currently, neonatal intensive care units across India face a growing burden of multidrug-resistant organisms such as Klebsiella and Acinetobacter. While the World Health Organization (WHO) recommends ampicillin and gentamicin as first-line therapy, increasing antimicrobial resistance (AMR) has reduced their effectiveness. Furthermore, blood cultures fail to identify the causative organism in nearly 80% of suspected neonatal sepsis cases, leading clinicians globally to employ more than 200 different antibiotic regimens.

To bridge this evidence gap, the NeoSep1 trial utilizes an innovative Personalised Randomised Controlled Trial (PRACTical) design. This allows treating physicians to identify clinically appropriate antibiotic regimens for each newborn before random assignment, ensuring real-world applicability while promoting responsible antimicrobial stewardship.

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