A groundbreaking clinical trial, NeoSep1, is underway in several countries, including Kenya, to address the escalating crisis of antibiotic resistance in newborns with sepsis. This initiative focuses on repurposing older, often overlooked antibiotics to fight infections that are increasingly unresponsive to current treatments.
The Global Threat of Neonatal Sepsis
Each year, an estimated 800,000 newborns die from sepsis worldwide, with Africa accounting for 28% of those deaths. The problem is worsening because bacteria are evolving resistance to standard antibiotics, leading to up to 214,000 neonatal deaths annually from antimicrobial-resistant infections. This is not simply a medical problem; it highlights the broader consequences of antibiotic overuse and the slow pace of new drug development.
NeoSep1: A Novel Approach to Drug Resistance
The NeoSep1 trial, led by the Global Antibiotic Research and Development Partnership (GARDP), is systematically testing combinations of existing antibiotics to identify safe and effective treatments for neonatal sepsis. Researchers have already narrowed down options to eight potential regimens, including two older drugs – fosfomycin and flomoxef – which have never been widely used in Africa for sepsis despite decades of efficacy elsewhere. These drugs, originally developed in the 1970s and 1980s, are now generic and affordable, offering a practical solution where new antibiotic development is too expensive and slow.
The Science Behind Repurposing
The trial involves exposing bacteria to different antibiotic combinations to determine which ones halt their growth. This direct testing approach, conducted at research facilities like the Kemri-Wellcome Trust Research Programme (KWTRP) in Kilifi, Kenya, allows for rapid identification of effective treatments. However, diagnosis can still take up to five days, underscoring the urgency of faster diagnostic methods in sepsis cases.
The Impact on Future Guidelines
The study, involving 3,000 babies across eight countries by 2029, aims to inform the World Health Organization and national governments to revise existing treatment guidelines. The ultimate goal is not just to identify the best antibiotic combinations but also to minimize unnecessary antibiotic exposure, which fuels resistance.
The success of NeoSep1 could dramatically improve survival rates and reduce the burden of sepsis in vulnerable populations. By reviving older drugs and optimizing their use, the trial offers a practical, cost-effective solution to a growing global health challenge.
