Researchers gather in New Delhi to kick off observational study for newborns with sepsis


3 Jul 2018

GENEVA AND NEW DELHI – Over 80 researchers from 11 countries are meeting in New Delhi today to kick off an observational study to understand sepsis in newborns and current antibiotic prescribing practices. This is part of the Global Antibiotic Research and Development Partnership’s (GARDP’s) broader programme to develop new and improved antibiotic treatments for newborns. The observational study, led by GARDP, is benefiting from US$2 million funding from Bill & Melinda Gates Foundation to support study sites in Bangladesh, India, Kenya, South Africa, and Uganda.

While significant progress has been made in recent years to improve child health globally, including a 50 percent reduction in child mortality since 1990, the number of preventable deaths in newborns remains unacceptably high. Neonatal deaths now represent 44 percent of all deaths in children under the age of five1. Of great concern, is the estimated 214,000 deaths in newborns attributable to drug-resistant infections2.

GARDP’s observational study is responding to this global concern. The data generated from the study will inform GARDP’s ambition to develop and deliver new antibiotic treatments for newborns with drug-resistant bacterial infections. Limited research on newborns has resulted in a lack of evidence about appropriate treatment of serious and drug-resistant infections in this vulnerable population.

“We are grateful for Bill & Melinda Gates Foundation’s commitment. Antibacterial resistance is one of the main barriers to achieving the Sustainable Development Goal to reduce neonatal mortality,” said Dr Manica Balasegaram, Director of GARDP. “I am especially delighted that Ms Anupriya Patel, Honourable Minister for State, Ministry of Health and Family Welfare is able to join us as we kick-off our global observational study at a launch event co-hosted by the Indian Council of Medical Research and the World Health Organization.”

Sepsis, the body’s response to infection, can be life-threatening and poses a particular threat to newborns as their immune systems are not fully developed. Increasing rates of bacteria resistant to existing treatments are reported globally, with hospitalized newborns and infants at high risk of developing drug-resistant hospital-acquired infections. Newborns’ susceptibility to sepsis is further compounded by the challenges of diagnosing serious bacterial infections since symptoms and signs can be non-specific and difficult to detect.

About the observational study

The observational study is being carried out in hospitals/neonatal units in Bangladesh, Brazil, China, Greece, India, Italy, Kenya, South Africa, Thailand, Vietnam, and Uganda. The study focuses on collecting clinical information on babies with significant/clinical sepsis.

The study will generate a robust evidence base on how neonatal sepsis is managed which can be used as a basis for evaluating future interventions in neonates. Outcomes of interest will include mortality, antibiotic use, and duration of antimicrobial therapy – there are currently few data on these parameters.

About GARDP

GARDP is a not-for-profit research and development organization that addresses global public health needs by developing and delivering new or improved antibiotic treatments, while endeavouring to ensure their sustainable access. Initiated by the WHO and the Drugs for Neglected Disease initiative (DNDi), GARDP is an important element of WHO’s Global Action Plan on Antimicrobial Resistance that calls for new public-private partnerships to encourage research and development of new antimicrobial agents and diagnostics. Through the neonatal sepsis programme, GARDP aims to develop new, improved treatment regimens for the management of neonatal sepsis in settings with high prevalence of drug-resistant and extensively drug-resistant pathogens.

References

1 Liu L., et al. (2015) Global, regional, and national causes of child mortality in 2000–13, with projections to inform post-2015 priorities: an updated systematic analysis. The Lancet: 385: 430–40.
Laxminarayan R., et al. (2016) Access to effective antimicrobials: a worldwide challenge.The Lancet: 387; 168-75.

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