Infections among young infants (0–59 days old) including newborns (0–28 days old) are a major cause of mortality and must be identified and treated quickly and adequately to ensure survival and minimize morbidity. An estimated 2.3 million newborns die each year. Low- and middle-income countries bear the greatest mortality burden, with neonatal sepsis being a major contributor in these settings. In 2018, an estimated 15% of all newborn deaths globally were due to sepsis, a common outcome of unmanaged possible serious bacterial infections. Due to the need for early intervention and the lack of diagnostic tools, empirical antibiotic therapy is commonly included in sepsis protocols and results in the overuse of antibiotics. Inappropriate use of antimicrobials is a major contributor to rising antimicrobial resistance globally.
The aim of this target product profile (TPP) is to provide guidance for the development of tests that will enable early and accurate detection of sepsis or exclusion thereof, to ensure appropriate management and antibiotics administration in young infants, including newborns, with the aim of improving patient outcomes, decreasing health-care costs, and supporting antimicrobial stewardship.
The World Health Organization is now seeking feedback on this draft TPP from experts in the industry, product developers, the scientific community, implementers, clinicians, and health programme personnel currently involved in the management and control of disease.
Comments may be submitted by individuals or organizations and will be accepted until 25 February 2025. Proposed revisions arising from this public consultation will be considered by the TPP development group before the TPP is finalized.
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