Antibiotic resistance when treating sepsis in newborns is emerging as a concern that is resulting in more deaths of babies, warns a new study by clinicians in Kenya, Uganda, South Africa, Bangladesh, Brazil, China, Greece, India, Italy, Thailand and Vietnam.

The study investigating newborn babies suffering from sepsis and conducted from 2018 to 2020 found that nearly one in five infants died as a result of culture-positive sepsis.

Sepsis, a life-threatening bloodstream infection, affects up to three million babies a year globally and every year, 214,000 newborn babies, mostly in low- and middle-income countries (LMICs), die of sepsis that has become resistant to antibiotics.

“The study exposed the glaring reality of antibiotic-resistant infections, especially in hospitals in LMICs, where we are often faced with a shortage of nurses, beds and space. The risk of infections is very high, and most infections are resistant to antibiotics.

If an antibiotic doesn’t work, the baby often dies. This urgently needs to change. We need antibiotics that will cover all bacterial infections,” said Sithembiso Velaphi, head of paediatrics at Chris Hani Baragwanath Academic Hospital in Johannesburg.

The study by Global Antibiotic Research and Development Partnership (GARDP) and co-led by University College London, highlights a worryingly wide variation in treatment.

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The paper noted that more than 200 different antibiotic combinations were used by hospitals, with frequent switching of antibiotics due to high resistance to treatments.

The findings have been published in a paper in PLOS Medicine.

Many physicians were forced to use antibiotics such as carbapenems – classified by the World Health Organisation as “Watch” antibiotics because they are recommended only for specific, limited indications as they need to be preserved – due to the high degree of antibiotic resistance to recommended treatments in their units.

Similarly, last-line antibiotics were prescribed to 15 percent of babies.

Tools developed

Klebsiella pneumoniae was the most common pathogen isolated. It is usually associated with hospital-acquired infections.

The team has developed two tools for possible use in clinical trials and in any neonatal intensive care unit worldwide.

The NeoSep Severity Score, based on 10 clinical signs and symptoms, could be used by clinicians to identify newborns who have a high risk of dying, and ensure they get special attention more quickly.

The NeoSep Recovery Score uses many of the same clinical signs and symptoms and could provide clinicians with key information on whether to escalate treatment.

The study also aims to inform WHO guidelines on treatment for sepsis in newborn babies.

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“Organisms evolve, drug resistance changes; that is why clinical guidelines for neonatal sepsis need constant adaptation.

Updating guidelines relies on recent and good evidence, so this observational study is a significant step towards better treatment,” said Wolfgang Stöhr, statistician for the observational study at the MRC Clinical Trials Unit at UCL.

The neonatal sepsis trial (NeoSep1) is being conducted at Chris Hani Baragwanath Academic Hospital in Soweto, Johannesburg, Tygerberg Hospital in Cape Town and Kilifi County Hospital in Kenya.

The trial will also look at appropriate formulations and dosages for newborn babies. The trial will be expanded to other countries and regions from 2024, with a target of recruiting up to 3000 newborns overall.