Leading public health experts are calling for urgent action to develop antibiotics for newborn babies, a population that is particularly vulnerable to antibiotic resistance.
Each year, there are an estimated three million cases of neonatal sepsis causing up to 570,000 deaths, many due to a current lack of effective antibiotics, according to a papers published by international experts in the field of antimicrobial resistance (AMR).
Last Friday, the World Health Organization (WHO) released a report that shows a high level of antibiotic resistance from a number of bacteria that cause life-threatening bloodstream infections, and increasing resistance from bacteria that cause common infections.
The Global Antimicrobial Resistance and Use Surveillance System (GLASS) report shows high levels (above 50%) of resistance in the largely hospital-acquired bacteria, Klebsiella pneumoniae and Acinetobacter spp. These require treatment with last-resort antibiotics such as carbapenems, but 8% of bloodstream infections caused by Klebsiella pneumoniae were even resistant to carbapenems.
Meanwhile, over 60% of Neisseria gonorrhoea isolates showed resistance to a common oral antibacterial ciprofloxacin. Over 20% of E.coli isolates – the most common cause of urinary tract infections – were resistant to both first-line drugs (ampicillin and co-trimoxazole) and second-line treatments (fluoroquinolones).
New WHO report on #AntimicrobialResistance reveals very high levels of resistance in common bacteria frequently causing bloodstream infections in hospitals.
Infection prevention & control is critical to stop the spread and save lives.
More: https://t.co/8dGqw5KgZT pic.twitter.com/XGC2I7KbwB
— World Health Organization (WHO) (@WHO) December 9, 2022
Few drug trials for newborn antibiotics
Despite the rising number of newborn deaths caused by AMR, very few effective antibiotics have been studied to treat serious bacterial infections such as neonatal sepsis.
Of the 40 antibiotics approved for use in adults since 2000, only four have included dosing information for newborns in their labels, according to the AMR experts.
In addition, far fewer trials investigating new antibiotics are currently being conducted in neonates than in adults: six neonatal trials compared with 43 adult trials.
“On any given day, up to 40% of infants admitted to a neonatal intensive care unit are prescribed antibiotics, with an estimated 90% exposed to antibiotic medications over the duration of their stay in the intensive care unit,” according to the paper.
“Many of these antibiotics are prescribed off-label because of the perceived or documented need for empirical or targeted therapy of MDR pathogens. Such prescribing risks reducing efficacy or increasing toxicity be – cause of under- or over-dosing; it also increases the potential for antimicrobial resistance selection pressure because of suboptimal dosing.”
The experts, including researchers from the Global Antibiotic Research & Development Partnership (GARDP) and Penta Child Health Research, propose an international, inter-disciplinary network to accelerate the development of antibiotics for newborn babies.
“There is an urgent need to identify high-priority antibiotics to understand which ones work best and safely in children, and then make them available where they are needed,” said Mike Sharland from St George’s, University of London, and a member of the Antimicrobial Resistance Program at Penta.
According to recent estimates, about 2.3 million newborns die of severe bacterial infections each year. An increasing number of babies under 28 days’ old are becoming resistant to currently used antibiotics. Over the last decade, AMR has worsened to the point that around 50–70% of common pathogens exhibit a high degree of resistance to available first- and second-line antibiotics.
Working together collaboratively could speed up both development and access to urgently needed antibiotics for newborns.
“By bringing together academic clinical trial networks, international research networks, regulators, donors, government and industry sponsors, these public-private partnerships can leverage their multi-disciplinary expertise and funding to speed up access to antibiotics and facilitate the update and routine implementation of global treatment guidelines,” said Carlo Giaquinto, President of the Penta Foundation.
The paper outlines how a stakeholder group could work together to define a Neonatal Priority Antibacterial List, and to standardize regulatory criteria.
“We need to move fast to develop guidelines and protocols on the use of antibiotics, as well as develop new antibiotics,” said Professor Sithembiso Velaphi, Head of Pediatrics at the Chris Hani Baragwanath Academic Hospital in Soweto, South Africa.
“We have the opportunity to prevent more unnecessary deaths of babies from these severe and preventable infections by intervening, quickly, equitably, and safely. It is also critical that all efforts must be made to prevent these infections by ensuring that all healthcare facilities and providers adhere to infection prevention and control protocols.”
GARDP, Penta, St George’s, University of London (SGUL) and other key partners are partnering on an upcoming clinical trial starting in South Africa in the next few months before being expanded to other countries to evaluate more effective neonatal treatment regimens to overcome resistance to current treatments, especially in low- and middle-income countries.
Image Credits: 20 May 2021South AfricaKL Schermbrucker/GARDP.
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