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 trial aims to identify safe and effective antibiotic combinations for treating antimicrobial-resistant neonatal sepsis.
NeoSep1 is a multicentre study sponsored by the Global Antibiotic Research and Development Partnership (GARDP), a not-for-profit organisation working on drug-resistant infections. It aims to enrol 3,000 newborns across Asia and Africa by the end of 2028. Newborns have already been enrolled in Ghana, Kenya and South Africa, and the study is underway in India, Vietnam and Pakistan. It is expected to expand to Malaysia, Bangladesh and Uganda.
The stated objective is to find the most effective antibiotic combinations for newborns with sepsis and to build evidence-based treatment strategies for Low- and Middle-Income Countries (LMICs).
The trial uses the PRACTical (Personalised Randomised Controlled Trial) design. Treating physicians first identify the clinically appropriate antibiotic regimens for each newborn, and only then are the regimens randomly assigned. This keeps the findings applicable to real-world practice and promotes responsible antimicrobial stewardship.
Neonatal sepsis is a severe, life-threatening bloodstream infection in infants younger than 90 days. Early-onset sepsis occurs within the first 72 hours of life and is typically caused by pathogens transmitted from the mother before or during delivery. Late-onset sepsis occurs between 72 hours and 90 days and is generally acquired from the hospital environment or the community.
Prematurity and low birth weight raise vulnerability, as do prolonged rupture of membranes, maternal infections and unhygienic delivery practices. Prolonged hospitalisation and invasive interventions such as ventilators, intravenous lines and central venous catheters add to the risk of hospital-acquired infection. Symptoms are often non-specific and the condition can worsen rapidly, so suspected cases need immediate care. Treatment starts with broad-spectrum antibiotics after blood cultures are collected, and is later adjusted using antimicrobial susceptibility results.
Sepsis is the second most common cause of neonatal death and is responsible for more than one million deaths globally every year. In India it contributes to an estimated 30%–40% of neonatal deaths, around 2–2.5 lakh preventable deaths annually.
In high-income countries, Group B Streptococcus and E. coli are the major causes of neonatal sepsis. In India it is predominantly caused by Gram-negative and often multidrug-resistant bacteria, particularly Klebsiella pneumoniae, E. coli, Acinetobacter species and Pseudomonas aeruginosa. These organisms are often resistant to multiple drugs, which makes treatment exceedingly difficult and is why localised, evidence-based data are required.
Rising resistance to commonly used antibiotics is reducing the effectiveness of affordable treatments and increasing reliance on expensive or last-resort drugs. Diagnosis adds to the difficulty. Blood cultures, the gold standard, take up to 48-72 hours and often fail to identify the organism because of small sample volumes or prior antibiotic exposure. Doctors then have to rely on empirical broad-spectrum antibiotics.
NeoSep1 is meant to identify safe, effective and affordable antibiotic combinations for newborns, and to generate India-specific evidence on regimens for drug-resistant neonatal sepsis.
With reference to the NeoSep1 clinical trial, consider the following statements:
Which of the statements given above are correct?
With reference to the PRACTical design used in the NeoSep1 trial, which one of the following best describes it?
Consider the following statements:
Statement-I: In India, neonatal sepsis is predominantly caused by Gram-negative and often multidrug-resistant bacteria, so localised, evidence-based data are required.
Statement-II: In high-income countries, Group B Streptococcus and E. coli are the major causes of neonatal sepsis.
Which one of the following is correct in respect of the above statements?
