Actively Recruiting
Validation of Biomarkers Performance to Reduce Antibiotics overUse in newBorns With Suspected Clinical Signs of InfectionS
Led by Hospices Civils de Lyon · Updated on 2025-09-03
358
Participants Needed
3
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Validation of Biomarkers Performance to Reduce Antibiotics overUse in newBorns With Suspected Clinical Signs of InfectionS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient hospitalized in the NICU of one of the two recruiting centers at the time of inclusion
- Patients aged 27 7 days
- Patients weighted 27 500 g the day of blood sample
- Patients with suggestive signs of LOS including at least one of the following: Fever > 38�B0C; tachycardia > 160bpm; capillary refill time > 3 seconds; grey and/or pale skin complexion; apnea/bradycardia syndrome; bloating; vomiting; rectal bleeding; hypotonia; lethargy; seizures without other obvious cause; increased ventilatory support and/or increased FiO2; cutaneous rash; inflammation at the needle-puncture site of the central venous catheter; or any other condition for which the clinician suspected an infection
- Patients with a standard of care blood sampling, including at least a blood culture
You will not qualify if you...
- Patient treated with antibiotics for a bacteriologically confirmed infection at the time of sampling or within 48 hours prior to sampling
- Patient who underwent surgery within the previous 7 days
- Patients vaccinated within the previous 7 days
- Patient who received treatment with systemic corticosteroid therapy in the 48 hours prior to sampling
- Patient with severe combined immunodeficiency
- Opposition from parent(s)/guardian(s)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
neonatal Intensive care unit, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, France
Bron, France, 69500
Actively Recruiting
2
Hôpital Couple-Enfant - CHU Grenoble Alpes
Grenoble, France, 38700
Actively Recruiting
3
Neonatal intensive care unit, Hôpital femme-maternité
Nantes, France, 44300
Actively Recruiting
Research Team
M
Marine BUTIN, Pr
CONTACT
S
Sophie TROUILLET-ASSANT
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here