Condition: Neonatal Late Onset Sepsis · Sponsor: Hospices Civils de Lyon
Late-onset neonatal sepsis (LOS), occurring in newborn of at least 7 days of life, is frequently observed in Neonatal Intensive Care Units (NICUs) and potentially severe (mortality, neurologic and respiratory impairments). Despite its high prevalence, a reliable diagnostic remains difficult. Currently, nonspecific clinical signs that might be related to other neonatal conditions such as prematurity and birth defects, are used to determine the diagnosis of LOS. Laboratory results of biological markers, such as C-Reactive Protein (CRP) and Procalcitonin (PCT) are often delayed in comparison with LOS onset. Blood culture results are too late and lack sensitivity. This explains why excessive antibiotic use is observed in a large proportion of NICU hospitalized newborns. This results in an increased antibiotic resistance, microbiota modification, neonatal complications (pulmonary, ophthalmologic and neurologic) and mortality. A previous study (EMERAUDE) aimed to identify new biomarkers to early exclude the diagnosis of LOS, in order to limit antibiotic overuse. This study including 230 neonates revealed high performances of IL6, IL10, NGAL and combinations of PCT/IL10 and PTX3/NGAL. The main objective of the present study will be to validate the performances of these biomarkers in another cohort. The secondary objectives will be to explore transcriptomic biomarkers and salivary biomarkers.
This description comes directly from the study's public registry record.
Marine BUTIN, Pr · +33 4 27 85 52 84 · marine.butin@chu-lyon.fr
Sophie TROUILLET-ASSANT · +33 4 72 67 87 80 · sophie.trouillet-assant@chu-lyon.fr
Always discuss trial participation with your own doctor first.
| neonatal Intensive care unit, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, France | Bron, France | Recruiting |
| Hôpital Couple-Enfant - CHU Grenoble Alpes | Grenoble, France | Recruiting |
| Neonatal intensive care unit, Hôpital femme-maternité | Nantes, France | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06058819