Indian newborns join global race to beat deadly drug-resistant sepsis

India has enrolled its first newborn in the global NeoSep1 trial at JIPMER, Puducherry. The study will test antibiotic combinations for neonatal sepsis as resistance weakens standard treatments.

In Short

• Sepsis causes roughly 30-40 per cent of newborn deaths in India
• Drug-resistant infections make long-used hospital antibiotics increasingly unreliable for newborn care
• The study aims to enrol 3,000 babies across Asia and Africa

India has enroled its first newborn in a landmark global clinical trial that could reshape how doctors treat one of the biggest killers of infants, neonatal sepsis, at a time when the antibiotics used for decades are rapidly losing their power.

Sepsis in newborns, or neonatal sepsis, is a serious medical condition that occurs when a baby younger than 28 days old has a life-threatening response to an infection.

Bacterial infections are the most common cause of neonatal sepsis.

The first baby has been recruited at the Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, marking India's entry into the NeoSep1 trial led by the Global Antibiotic Research and Development Partnership (GARDP).

Hospitals in Rohtak have also begun enrolling patients, while Mumbai is expected to join shortly.

India and Pakistan are the first countries in Asia to participate in the study, which aims to enrol 3,000 newborns across Asia and Africa by 2028. The trial is already underway in Ghana, Kenya and South Africa, with Vietnam, Bangladesh, Malaysia and Uganda set to join.

Sepsis is the second leading cause of neonatal mortality in India, after prematurity or low birth weight, accounting for roughly 30- 40 percent of all newborn deaths.

Antimicrobial resistance (AMR), when disease causing bacteria or other pathogens develop resistance to commonly used antimicrobials or antibiotics, is a top-tier public health crisis in the country with drug-resistant bloodstream infections, lower respiratory infections, and hospital-acquired superbugs causing the most urgent concern.

Overall, AMR causes approximately 300,000 direct deaths annually in India, with nearly 10 lakh deaths associated with drug-resistant infections.

A RACE AGAINST RESISTANCE

The timing is significant for India, where newborn infections remain a major cause of infant deaths and antimicrobial resistance (AMR) has made treatment increasingly uncertain.

Every year, up to three million babies worldwide develop neonatal sepsis, a life-threatening bloodstream infection that can overwhelm a newborn's still-developing immune system within hours.

While antibiotics have long been the cornerstone of treatment, many of the commonly used drugs are no longer effective against resistant bacteria, particularly in hospitals.

The consequences are already visible.

According to the Global Research on Antimicrobial Resistance (GRAM) study, an estimated 238,500 newborn deaths across South Asia, Southeast Asia and Oceania in 2019 were linked to drug-resistant infections. More than 63,000 of these deaths occurred because the bacteria no longer responded to standard antibiotics.

For India, which has one of the world's highest burdens of neonatal infections and widespread antibiotic resistance, finding treatments that still work is no longer just a research priority but a clinical necessity.

FINDING WHAT WORKS

Unlike conventional trials that compare only one treatment against another, NeoSep1 will simultaneously evaluate and rank multiple antibiotic combinations using an innovative personalised randomised trial design. The idea is to identify therapies that are not only safe and effective but also practical for hospitals facing different resistance patterns.

The evidence generated could eventually shape both national and global guidelines for treating neonatal sepsis, especially in low- and middle-income countries where access to newer antibiotics remains limited.

The study builds on an earlier phase completed in South Africa and Kenya in 2023, which established safe dosing for the antibiotics fosfomycin and flomoxef in newborns when used alongside other medicines.

"Every day doctors face the heartbreaking reality of losing babies to sepsis because safe and effective treatment options are limited," said Dr Nishad Plakkal, principal investigator of the NeoSep1 trial in India and Head of Neonatology at JIPMER. "Having the right antibiotics at the right dose can tip the balance between life and death. This trial offers hope to change that."

GARDP's Children's Antibiotics Project leader Sally Ellis said the world has reached a critical point where antibiotics that have served newborns for decades are failing against resistant infections in many hospitals.

The trial, she said, aims to equip neonatologists with evidence-backed treatment options and give babies with sepsis a better chance of survival.

For India, where the twin threats of sepsis and antimicrobial resistance intersect with one of the world's largest birth cohorts, the study could help answer one of neonatal medicine's most urgent questions: which antibiotics still save lives when the old ones no longer do.

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