India Joins NeoSep1 Trial to Combat Neonatal Sepsis:
The Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, has become the first centre in India to enrol a newborn in the NeoSep1 international clinical trial, which aims to identify safe and effective antibiotic combinations for treating antimicrobial-resistant neonatal sepsis.NeoSep1 Clinical Trial is a multicentre, international clinical trial sponsored by the Global Antibiotic Research and Development Partnership (GARDP), a not-for-profit organization dedicated to treating drug-resistant infections.The trial aims to enroll 3,000 newborns across Asia and Africa by the end of 2028.The study has enrolled newborns in Ghana, Kenya, and South Africa and is currently underway in India, Vietnam, and Pakistan.It is also expected to expand to Malaysia, Bangladesh, and Uganda.Core Objectiveis To identify the most effective antibiotic combinations for newborns suffering from sepsis and to generate evidence-based treatment strategies specifically tailored for Low- and Middle-Income Countries (LMICs).The trial utilizes the PRACTical (Personalised Randomised Controlled Trial) design.This allows treating physicians to identify clinically appropriate antibiotic regimens for each newborn before random assignment, ensuring real-world applicability and promoting responsible antimicrobial stewardship.India’s inclusion is critical because the pathogen profile causing neonatal sepsis in Indian hospitals differs vastly from that in high-income countries, requiring localized, evidence-based data.
