The Global Antibiotic Research and Development Partnership (GARDP) said yesterday that an international clinical trial investigating treatment options for newborns with sepsis has expanded to India.

Led by GARDP and its partners, the NeoSep1 trial aims to enroll 3,000 newborns in Asia and Africa by the end of 2028 to identify safe and effective antibiotic treatment regimens that can reduce deaths from neonatal sepsis caused by drug-resistant bacteria. In addition to India, newborns have also been enrolled in Ghana, Kenya, and South Africa. Hospitals in Vietnam, Pakistan, Malaysia, Bangladesh, and Uganda are slated to join the study.

An estimated 3 million newborns each year develop sepsis, which occurs when an infection triggers an overwhelming inflammatory reaction that can lead to tissue damage, organ failure, and death. More than 90% of neonatal sepsis deaths occur in low- and middle-income countries (LMICs). 

Rising rates of antibiotic resistance in LMICs have made the problem worse by reducing the effectiveness of recommended antibiotic regimens. Studies have found extremely high resistance to the combination of ampicillin and gentamicin, which is currently recommended by the World Health Organization for empiric treatment of neonatal sepsis.

Sally Ellis, who leads GARDP's Children's Antibiotics Programme, said the trial is about "giving neonatologists new tools, and giving babies with sepsis a fighting chance at life.”

“Today, we stand at a tipping point," Ellis said in a press release. "The antibiotics for newborns that we have relied on for decades are failing against resistant infections, in many hospital settings." 

The trial will evaluate and rank multiple antibiotic regimens for newborns with sepsis, which will help clinicians choose effective treatments and inform updates to international and national treatment guidelines.