Neonatal sepsis is life-threatening infection in newborns caused by bacteria or fungi. The first line of treatment includes a broad-spectrum of antibiotics, often misused. Over time these bacteria, viruses, fungi and parasites no longer respond to the antibiotics making infections harder to treat.
More details on specific activities can be found on the GARDP website.
Global Neonatal Sepsis Observational Study (NeoOBS) is a in collaboration between GARDP, St George’s University of London, Penta, University of Antwerp, MRC Clinical Trial Unit at University College London and 19 hospitals mainly in limited-resource settings. NeoOBS was launched in July 2018 to develop new and improved treatment regimens for the management of neonatal sepsis in settings with high prevalence of multidrug-resistant and extensively drug-resistant pathogens.
The NeoOBS study will inform an upcoming neonatal sepsis clinical trial. Robust evidence on the safety and efficacy of new antibiotic combinations compared to the WHO-recommended regimen and existing antibiotic combinations for the treatment of neonatal sepsis is vitally important.
The primary objective of NeoOBS was to assess mortality rates of hospitalised infants being treated with significant sepsis. Secondary objectives included describing clinical presentation and recovery, sepsis management and microbiological epidemiology. This involved the collection of routine clinical, laboratory and antimicrobial therapy data from approximately 3000 neonates less than 60 days old with clinically diagnosed sepsis. Patients were followed for 28 days.
This global multi-centre prospective study has completed recruitment in February 2020 with each site having recruited up to 200 neonates. Data from the study will be used to inform the design of future antibiotic treatment trials for neonatal sepsis.
To know more about the programme, read:
More details on specific activities can be found on the GARDP website.