NAIROBI, Kenya, Nov 30 – The Kenya Medical Research Institute (KEMRI)-Wellcome Trust is leading a major multi-country clinical trial aimed at developing safer and more effective treatments for neonatal sepsis, a leading cause of newborn deaths worldwide.
Neonatal sepsis — a severe bloodstream infection occurring within the first 28 days of life — accounts for more than 550,000 newborn deaths globally every year, according to the World Health Organization. Low- and middle-income countries carry the greatest burden, with rising antimicrobial resistance (AMR) making treatment increasingly difficult.
Christina Obiero, a research scientist at KEMRI-Wellcome Trust, told Capital FM that many antibiotics traditionally used to treat newborn infections are no longer working effectively.
“The antibiotics currently used were developed decades ago. Many are losing effectiveness due to resistance, and there’s limited evidence on the best combinations or doses for newborns,” Obiero said.
The NeoSep1 trial, led by the Global Antibiotic Research & Development Partnership (GARDP), will enroll 3,000 newborns across multiple countries. Kenya will contribute 600 participants from three facilities: Kilifi County Referral Hospital, Coast General Teaching and Referral Hospital, and Mbagathi Hospital. The trial operates under the broader SNIP-Africa project.
Unlike traditional trials that examine a single drug, NeoSep1 will test several new antibiotic combinations — including flomoxef and fosfomycin, either paired together or with amikacin — and compare them against standard treatments in hospitals.
The first phase, involving 65 newborns in Kenya and South Africa, focused on drug safety and helped determine the appropriate doses to move into the second phase. The next stage will test eight antibiotic combinations in newborns at moderate or high risk of death from sepsis.
Obiero said the study is a crucial step toward tackling both neonatal mortality and the growing AMR threat.
“Through partnerships, research innovation, and local capacity building, the Institute continues to act — protecting today’s patients while securing tomorrow’s treatments,” she said.
AMR remains one of the world’s most urgent health challenges. WHO estimates show that drug-resistant infections directly caused 1.27 million deaths in 2019 and contributed to nearly 5 million more. Misuse and overuse of antimicrobials in humans, animals, and agriculture continue to accelerate resistance, making common infections harder to treat and routine medical procedures riskier.
