New drug trial to treat sepsis in babies underway
Early-onset sepsis (in the first three days of birth) occurs due to transmission of infection from the mother during birth. Photo/FILE
What you need to know:
- Neonatal sepsis is an infection that affects about three million babies worldwide per year and is caused by a systemic bacterial infection. It is a major cause of paediatric deaths.
- The trial dubbed ‘NeoSep1’ aims to evaluate new combinations of existing antibiotics and compare them with existing treatment regimens used in newborn babies with suspected neonatal sepsis.
A new clinical trial that hopes to advance the treatment of neonatal sepsis is underway.
Neonatal sepsis is an infection that affects about three million babies worldwide per year and is caused by a systemic bacterial infection. It is a major cause of paediatric deaths. The trial dubbed ‘NeoSep1’ aims to evaluate new combinations of existing antibiotics and compare them with existing treatment regimens used in newborn babies with suspected neonatal sepsis.
The study aims to assess the safety and efficacy of three new combinations of older antibiotics (fosfomycin- amikacin, flomoxef-amikacin, and flomoxef-fosfomycin) against the current standard of care.
It will also evaluate and validate the doses of two antibiotics (fosfomycin and flomoxef) for use in newborns. The researchers will use a new way of comparing antibiotic treatments with each other, called the Personalised Randomised Controlled Trial (PRACTical) design.
Kilifi County Hospital is one of the sites in Africa selected to be part of study. The two other sites are in South Africa. About 3,000 babies globally, including those from Kenya are targeted to be part of the research with prospects of advancing to other African countries next year.
Through the study, doctors will find it easy to decide on what drug to give babies. “We often have to treat babies with a combination of the antibiotics of last resort. On top of this we are not 100 per cent sure about how to dose these drugs. We’re dealing with fragile newborns, so we need to be aware of the potential toxicity of the antibiotics and dosages we use. This trial will help in giving us confidence that we are delivering more effective treatment,” said Adrie Bekker, Principal Investigator for the NeoSep1 trial at Tygerberg Hospital, Cape Town.
The trial is sponsored by the Global Antibiotic Research and Development Partnership (GARDP) in collaboration with the Medical Research Council Clinical Trials Unit at University College London (MRC CTU at UCL); St George’s, University of London (SGUL); and Penta.
In a statement, GARDP said that an increasing number of newborns are becoming resistant to antibiotic treatments recommended by the World Health Organisation, particularly the ampicillin-gentamicin regimen.
“Over the last decade, AMR has worsened to the point that around 50 to 70 per cent of common pathogens exhibit a high degree of resistance to available first- and second-line antibiotics. Over 214,000 newborn babies die of drug-resistant neonatal sepsis every year, mostly in low- and middle-income countries (LMICs),” showed the statement.
Seamus O’Brien, Director of Research and Development at GARDP said that limited treatment options result in many babies’ deaths.
“The NeoSep1 trial is an opportunity to shift this trajectory by identifying new antibiotic combinations that we can tailor to treat neonatal sepsis in settings where there is widespread resistance to current recommended options. This is vital if we are going to address the impact of antimicrobial resistance on the burden of disease related to neonatal sepsis,” he said.
