Abstract
Conducting collaborative and comprehensive epidemiological research on neonatal sepsis in low- and middle-income countries (LMICs) is challenging due to a lack of diagnostic tests. This prospective study protocol aims to obtain epidemiological data on bacterial sepsis in newborns and young infants at Kamuzu Central Hospital in Lilongwe, Malawi. The main goal is to determine if the use of whole blood transcriptome host immune response signatures can help in the identification of infants who have sepsis of bacterial causes. The protocol includes a detailed clinical assessment with vital sign measurements, strict aseptic blood culture protocol with state-of-the-art microbial analyses and RNA-sequencing and metagenomics evaluations of host responses and pathogens, respectively. We also discuss the directions of a brief analysis plan for RNA sequencing data. This study will provide robust epidemiological data for sepsis in neonates and young infants in a setting where sepsis confers an inordinate burden of disease.
Highlights
One of the challenges of severe infection and related illness is the overlap of terms such as sepsis / severe infection / bacterial infection
Any further responses from the reviewers can be found at the end of the article Introduction Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection[1]
Sepsis can be due to a variety of pathogens including viruses, fungi (e.g. Candida) and bacteria
Summary
One of the challenges of severe infection and related illness is the overlap of terms such as sepsis / severe infection / bacterial infection. These terms are used interchangeably in multiple settings, when the implications of the different nuances may be significant.
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