Global NeoSep1 trial expands to India to tackle neonatal sepsis
07 Jul 2026
NeoSep1, a major international clinical trial evaluating new antibiotic combinations for newborn babies with sepsis, has expanded its global recruitment to India. The first infant in the country was enrolled at Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry.
The expansion of NeoSep1 into India marks an important step in extending the trial across the Asia-Pacific region, reflecting both the scale of the challenge posed by neonatal sepsis and antimicrobial resistance, and the partnership's capacity to deliver complex, multi-country clinical trials where the need is greatest.
Neonatal sepsis, a life-threatening infection, affects up to 3 million babies per year globally. It has become increasingly hard to treat, as about 40% of infections are resistant to standard antibiotic treatments. More than 214,000 newborn babies die of drug-resistant neonatal sepsis every year, mostly in low- and middle-income countries.
The NeoSep1 trial is testing and ranking antibiotic combinations for neonatal sepsis. It aims to recruit 3,000 newborns across Asia and Africa by the end of 2028.
NeoSep1 uses a new methodology called (Personalised Randomised Controlled Trial (PRACTical) design. Developed by the UCL Innovative Clinical Trials Unit (formerly known as MRC Clinical Trials Unit at UCL), this innovative approach addresses challenges such as the lack of a single standard of care and the wide variation in patterns of antibiotic resistance across different parts of the world.
With clinicians worldwide using more than 200 different antibiotic regimens and limited evidence to guide treatment decisions, a conventional trial design would be difficult to implement and may not reflect real-world clinical practice. The PRACTical design allows clinicians to choose the reasonable antibiotic regimens for each baby, then randomises between them, making it possible to compare multiple treatments simultaneously.
NeoSep1 is led by the Global Antibiotic Research and Development Partnership (GARDP) in collaboration with the Innovative Clinical Trials Unit (InCTU), City St George's, University of London, and Penta. The trial draws on the trial management and methodological expertise of the InCTU and builds on the PRACTical methodology.
Further information: