A groundbreaking clinical trial, known as NeoSep1, is testing new combinations of existing antibiotics to treat sepsis in newborns. The infection causes an estimated 800,000 neonatal deaths each year worldwide, with antimicrobial resistance (AMR) contributing to up to 214,000 of these fatalities.
Led by the Global Antibiotic Research and Development Partnership (GARDP), the trial is running in eight countries, including Kenya, South Africa, India, and Vietnam. Researchers aim to enrol 3,000 babies by 2029, with 600 from three Kenyan clinics. The study compares eight antibiotic regimens, including two older drugs—fosfomycin and flomoxef—that have never been used in Africa to treat sepsis.
Fosfomycin, developed in the 1970s, and flomoxef, from the 1980s, are now generic and affordable. 'What we’re doing is repurposing them to treat sepsis,' said Christina Obiero, principal investigator at Kilifi County Hospital. Sally Ellis, GARDP project leader, noted that the variety of antibiotics currently used 'encourages bacteria to become resistant.'
The first phase confirmed safe dosages for three new combinations. In the second phase, these treatments will be tested against the infections. Researchers also expose bacteria to different antibiotics to determine which are effective. Rapid identification and treatment are critical, as sepsis can cause a newborn’s condition to deteriorate within seconds.
