Geneva, 12 June 2025 – A landmark clinical trial, aimed at evaluating life-saving antibiotic combination treatment options for newborns with sepsis, has been expanded to include hospitals across nine countries in Africa and Asia.  

Starting with Tygerberg Hospital in Cape Town, this second part of GARDP’s international clinical trial will include Chris Hani Baragwanath Hospital in Johannesburg, as well as hospitals in Kenya, Uganda, Ghana, India, Bangladesh, Pakistan, Malaysia and Vietnam, with a target of enrolling over 3,000 newborns by 2028.  

GARDP’s NeoSep1 trial is trailblazing as it is the first time that researchers will ascertain whether three combinations of older antibiotics, including fosfomycin, flomoxef and amikacin, will be safe and effective in treating newborns with sepsis. They will be ranked against five commonly used antibiotic regimens for neonatal sepsis. The overall goal is to identify optimal treatments that could reduce the number of newborns dying from drug-resistant sepsis.   

Based on the trial results, GARDP hopes to identify one or more effective treatment regimens for neonatal sepsis and establish sources of quality-assured supply. This complements GARDP’s objective to expand access to antibiotic treatments for newborns with sepsis.   

Part 1 of the NeoSep1 trial, conducted in South Africa and Kenya in 2023, assessed and validated the appropriate dose for two antibiotics (fosfomycin and flomoxef) for use in newborns. 

Neonatal sepsis affects up to three million babies a year globally, with 250,000 babies in Africa alone dying from sepsis every year. The crisis is exacerbated as an increasing number of newborns are becoming resistant to WHO-recommended antibiotic treatments. 

Through the clinical trial, GARDP aims to provide evidence to help inform WHO, national and institutional policy on effective antibiotic treatment regimens for newborn babies with sepsis.  

NeoSep1 is sponsored by the Global Antibiotic Research & Development Partnership (GARDP) in collaboration with the Medical Research Council Clinical Trials Unit at University College London (MRC CTU at UCL); City St George’s, University of London (SGUL); and Penta. 

The NeoSep1 trial also forms part of a five-year project by a consortium of African and European partners called SNIP-AFRICA. Funded by EDCTP3 and led by Penta, it aims to reduce mortality among newborns with sepsis in hospitals in Africa.  

Watch our video for a window into the global challenge of neonatal sepsis and what GARDP is doing about it.