In News:

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. The study seeks to identify safe and effective antibiotic combinations for treating antimicrobial-resistant neonatal sepsis, a major cause of newborn deaths in low- and middle-income countries.

What is the NeoSep1 Clinical Trial?

• The NeoSep1 Clinical Trial is a multicentre international study sponsored by the Global Antibiotic Research and Development Partnership (GARDP), a not-for-profit organisation working to combat drug-resistant infections.
• The trial plans to enrol3,000 newborns across Asia and Africa by 2028. It is currently underway in India, Vietnam and Pakistan, following enrolment in Ghana, Kenya and South Africa, and is expected to expand to Bangladesh, Malaysia and Uganda.
• Its primary objective is to generate evidence-based antibiotic treatment strategies for neonatal sepsis, particularly suited to the pathogen profile of Low- and Middle-Income Countries (LMICs).
• A key innovation of the study is its PRACTical (PersonalisedRandomised Controlled Trial) design, which allows clinicians to first identify appropriate treatment options for each newborn before random allocation. This approach improves real-world applicability while promoting responsible antimicrobial stewardship.
• India's participation is particularly significant because neonatal sepsis in Indian hospitals is predominantly caused by multidrug-resistant Gram-negative bacteria, unlike the pathogen profile observed in many high-income countries.

What is Neonatal Sepsis?

Neonatal sepsis is a life-threatening bloodstream infection occurring in infants below 90 days of age. Due to their immature immune systems, infections can spread rapidly, leading to septicaemia, pneumonia, meningitis, septic shock, multi-organ failure and death.

It is classified into:

• Early-Onset Sepsis (EOS): Occurs within the first 72 hours of life, usually due to infections transmitted from the mother during pregnancy or childbirth.
• Late-Onset Sepsis (LOS): Occurs between 72 hours and 90 days, generally acquired from the hospital environment or the community.

Causes and Risk Factors

The causative organisms vary across regions. In high-income countries, Group B Streptococcus (GBS) and E. coli are the predominant pathogens. In contrast, India's neonatal sepsis burden is largely driven by multidrug-resistant Gram-negative bacteria, particularly Klebsiella pneumoniae, E. coli, Acinetobacter spp. and Pseudomonas aeruginosa.

The risk is further increased by prematurity, low birth weight (LBW), maternal infections, prolonged rupture of membranes, unhygienic delivery practices, infected amniotic fluid, prolonged hospitalisation and invasive procedures such as ventilators and central venous catheters.

Burden in India

Neonatal sepsis remains the second leading cause of neonatal mortality and accounts for an estimated 30–40% of neonatal deaths in India, translating into nearly 2–2.5 lakh preventable deaths annually.

The growing challenge of antimicrobial resistance (AMR) has reduced the effectiveness of commonly used antibiotics, while blood culture-based diagnosis often requires 48–72 hours, delaying targeted therapy. These factors underscore the need for India-specific clinical evidence, making the NeoSep1 trial a crucial step towards developing effective and affordable treatment strategies.