Affiliation: | 1. University and University Clinics of Tartu, Tartu, Estonia 13. Institute of Microbiology, University of Tartu, Ravila 19, 50411, Tartu, Estonia 2. INSERM SC10–US 019, Villejuif, France 3. Immunological and Infectious Disease Unit, University Department of Pediatrics, Bambino Gesù Children’s Hospital, Rome, Italy 4. Clinica Pediatrica of Padova, Padova, Italy 5. Pediatric Clinic 1, Department of Pathophysiology and Transplantation, Università? degli Studi di Milano, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy 6. Paediatric Infectious Diseases Research Group, St George’s University, London, UK 7. Tallinn Children’s Hospital, Tallinn, Estonia 8. Infectious Diseases Unit, 3rd Department Pediatrics, Aristotle University School of Medicine, Hippokration Hospital, Thessaloniki, Greece 9. 2nd Department Neonatology, Aristotle University School of Medicine, Papageorgiou Hospital, Thessaloniki, Greece 10. NICU, Università degli Studi di Milano, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy 11. 1st Department Neonatology, Aristotle University School of Medicine, Hippokration Hospital, Thessaloniki, Greece 12. Clinic of Children Diseases, Faculty of Medicine, Vilnius University, Vilnius, Lithuania
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Abstract: | Late onset neonatal sepsis (LOS) has a high mortality and the optimal management is poorly defined. We aimed to evaluate new expert panel-derived criteria to define LOS and characterize the current management and antibiotic susceptibility of LOS-causing organisms in Europe. A prospective observational study enrolled infants aged 4 to 90 days in five European countries. Clinical and laboratory findings as well as empiric treatment were recorded and patients were followed until the end of antibiotic therapy. Failure was defined as a change of primary antibiotic, no resolution of clinical signs, appearance of new signs/pathogens or death. Antibiotic therapy was considered appropriate if the organism was susceptible to at least one empiric antibiotic. 113 infants (median age 14 days, 62 % ≤1500 g) were recruited; 61 % were culture proven cases (28 CoNS, 24 Enterobacteriaceae, 11 other Gram-positives and 6 Gram-negative non-fermentative organisms). The predictive value of the expert-panel criteria to identify patients with a culture proven LOS was 61 % (95 % CI 52 % to 70 %). Around one third of Enterobacteriaceae were resistant to ampicillin + or cefotaxime + gentamicin but only 10 % to meropenem. Empiric treatment contained a total of 43 different antibiotic regimens. All-cause mortality was 8 % with an additional 45 % classified as failure of empiric therapy, mainly due to change of primary antibiotics (42/60). Conclusions: The expert panel—derived diagnostic criteria performed well identifying a high rate of culture proven sepsis. Current management of LOS in Europe is extremely variable suggesting an urgent need of evidence-based guidelines. |