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Maternal colonisation and early-onset neonatal bacterial sepsis in The Gambia, West Africa: a genomic analysis of vertical transmission.
OBJECTIVES: To define bacterial aetiology of neonatal sepsis and estimate prevalence of neonatal infection from maternal genital tract bacterial carriage among mother-newborn pairs. METHODS: We carried out a cross-sectional study of newborns with clinical sepsis admitted to neonatal wards of three hospitals in The Gambia. Neonatal blood cultures and maternal genital swabs were obtained at recruitment. We used whole-genome sequencing (WGS) to explore vertical transmission for neonates with microbiologically confirmed bloodstream infection by comparing phenotypically matched paired neonatal blood culture and maternal genital tract bacterial isolates. RESULTS: We enrolled 203 maternal-newborn pairs. Two-thirds (67%; 137/203) of neonates presented with early-onset sepsis (days 0 - 6 after birth) of which 26% (36/137) were due to a clinically-significant bacterial pathogen. Blood culture isolates from newborns with early-onset sepsis due to Staphylococcus aureus (n=5), Klebsiella pneumonia (n=2), and Enterococcus faecalis (n=1), phenotypically matched their maternal genital tract isolates. Pairwise SNV comparisons showed differences of 12 - 52 SNVs only between maternal and newborn Staphylococcus aureus isolates, presumably representing vertical transmission with a transmission rate of 14% (5/36). CONCLUSIONS: We found low prevalence of vertical transmission of maternal genital tract colonisation in maternal-newborn pairs for early-onset neonatal sepsis in west African context. Identifying infection acquisition pathways among newborns is essential to prioritise preventive interventions, which could be targeted at mother or infection control in the hospital environment, depending on the major pathways of transmission
Conducting clinical research in a resource-constrained setting: lessons from a longitudinal cohort study in The Gambia.
Clinical research conducted to Good Clinical Practice (GCP) standards is increasingly being undertaken in resource-constrained low-income and middle-income countries (LMICs) settings. This presents unique challenges that differ from those faced in high-income country (HIC) contexts, due to a dearth of infrastructure and unique socio-cultural contexts. Field experiences by research teams working in these LMIC contexts are thus critical to advancing knowledge on successful research conduct in these settings. The Medical Research Council Unit The Gambia at London School of Hygiene and Tropical Medicine has operated in The Gambia, a resource-constrained LMIC for over 70 years and has developed numerous research support platforms and systems. The unit was the lead clinical collaborator in a recently completed Expanded Program on Immunization Consortium (EPIC) study, involving a multicountry collaboration across five countries including the USA, Canada, Belgium, Papua New Guinea and The Gambia. The EPIC study recruited and completed follow-up of 720 newborn infants over 2 years. In this paper, we provide in-depth field experience covering challenges faced by the Gambian EPIC team in the conduct of this study. We also detail some reflections on these challenges. Our findings are relevant to the international research community as they highlight practical day-to-day challenges in conducting GCP standard clinical research in resource-constrained LMIC contexts. They also provide insights on how study processes can be adapted early during research planning to mitigate challenges