The quest for new treatment options for newborns with drug-resistant sepsis took another step forward this week with the enrollment of the first baby in a trial of a combination of three older antibiotics.

It is the second part of a clinical trial by the Global Antibiotic Research and  Development Partnership (GARDP) to evaluate various antibiotic combinations for newborn babies with sepsis.

The first part of the trial, called NeoSep1, was launched in 2023 and it tested two antibiotics – fosfomycin and flomoxef. In this part of the trial, a third antibiotic, amikacin, has been added to the first two antibiotics.

The two combinations will be ranked against five commonly used antibiotic regimens for neonatal sepsis with the overall goal of identifying the optimal treatments to reduce neonatal deaths. 

Baby One was enrolled at Tygerberg Hospital in Cape Town, and GARDP aims to reach 3,000 newborn babies in hospitals across nine countries in Africa and Asia by 2028.

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

“Newborn babies are particularly vulnerable to infections, yet appropriate antibiotic treatments are often not available, especially in African countries,” said Sally Ellis, Children’s Antibiotics Project Leader for GARDP.

“If a baby picks up a serious infection, it can be a matter of life and death. New antibiotic treatments are sorely needed. GARDP’s clinical trial on neonatal sepsis hopes to help fill the treatment gap, so that babies with sepsis stand a better chance of survival and a good outcome.”

NeoSep1 is sponsored by the GARDP in collaboration with the Medical Research Council Clinical Trials Unit at University College London; City St George’s at the University of London, and the paediatric science research grou,p Penta.

The trial is part of a five-year project by a consortium of African and European partners called SNIP-AFRICA, which aims to reduce mortality among newborns with sepsis in hospitals in Africa.

Image Credits: Global Antibiotic Research and Development Partnership (GARDP).