International NeoSep1 trial for antimicrobial-resistant neonatal sepsis expands to India.
The international NeoSep1 trial, aimed at finding life-saving antibiotic combinations for newborns with sepsis, has expanded to India, with the first baby recruited at JIPMER, Puducherry. This trial addresses the critical issue of antimicrobial resistance, which is causing antibiotics relied upon for decades to fail against resistant infections. Neonatal sepsis is a leading cause of mortality, especially in low- and middle-income countries like India, where gram-negative organisms and multidrug resistance are prevalent. The study uses a Personalised Randomised Controlled Trial (PRACTical) design to evaluate and rank multiple antibiotic regimens, aiming to identify effective treatments and reduce newborn deaths.
Key Points
- The international NeoSep1 trial for neonatal sepsis has expanded to India, with the first recruitment at JIPMER, Puducherry.
- The trial aims to identify effective antibiotic combinations against antimicrobial-resistant neonatal sepsis.
- Neonatal sepsis is a major cause of newborn mortality, particularly in low- and middle-income countries.
- In India, gram-negative organisms and multidrug resistance are predominant causative agents of neonatal sepsis.
- The study uses a Personalised Randomised Controlled Trial (PRACTical) design to evaluate and rank antibiotic regimens.
Exam Facts
- NeoSep1 trial.
- First recruitment in India at Jawaharlal Postgraduate Education Institute of Medical and Research (JIPMER), Puducherry.
- Sponsored by GARDP Foundation, UCL Innovative Clinical Trials Unit, City St George's, University of London (SGUL), and Penta Foundation.
- Target: 3,000 newborns across Asia and Africa by end of 2028.
- Neonatal sepsis accounts for 30%-40% of all neonatal deaths in India (approx. 2,00,000-2,50,000 preventable deaths annually).
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