Scientists have revealed a new antibiotic that is safe to treat babies with a blood infection called neonatal sepsis.
Neonatal sepsis is a life-threatening blood infection that affects infants younger than three months, and requires prompt detection and treatment.
Clinical studies in Kenya show a dose of the antibiotic, Fosfomycin, is safe for babies with neonatal sepsis, which is usually caused by bacteria.
The NeoFosfo trial indicated that this is a significant development, as there are very few antibiotics specifically licensed to treat multidrug-resistant infections in babies.
The trial investigated the safety of Fosfomycin in 120 babies aged under 28 days who were hospitalised with clinically diagnosed sepsis at the Kilifi County hospital.
The trial was sponsored by the Global Antibiotic Research and Development Partnership and the Drugs for Neglected Diseases initiative.
“This is a very encouraging outcome for the treatment of neonatal sepsis and the care of babies who are hardest-hit by rising antimicrobial resistance (AMR). The study provides crucial evidence of the correct dosage of fosfomycin for newborns,” Clinical Trial manager Borna Nyaoke said.
The paper comes after recent data showed sub-Saharan Africa has the highest overall burden of AMR in the world, and that babies are most affected.
The GRAM study, published in The Lancet in January 2022, revealed that children under five years of age made up over half of the 255,000 people in sub-Saharan Africa who died in 2019 because of AMR.
The study indicated that newborn babies under 28 days are particularly vulnerable as their underdeveloped immune systems struggle to fight infections.
“This is complicated by drug resistance, as up to 40 per cent of bacterial infections are resistant to standard treatments. Many newborns die if they don’t get timely treatment, while others may have significant long-term consequences,” the study showed.
Christina Obiero, clinical investigator on the trial, from Kemri-Wellcome Trust Research Programme in Kilifi said there are very limited antibiotics in the pipeline.
“Safe and affordable antibiotic combinations effective against bacteria causing sepsis in babies are needed to improve survival. Our results are significant as they provide evidence that fosfomycin is safe and can now be taken forward into further clinical trials focusing on improving mortality outcomes for sepsis in babies,” said clinical investigator on the trial,” Obiero said.
According to the World Health Organization, fosfomycin is an antibiotic that is used in some countries to treat serious bacterial infections, but has rarely been used for treatment of serious infection in babies admitted to hospitals.
“It is expected that results obtained from this trial could inform WHO and local antibiotic treatment guidelines, as partners aim to demonstrate which combinations are safe and effective in treating neonatal sepsis,” Obiero said.
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