Validation of Biomarkers Performance to Reduce Antibiotics overUse in newBorns With Suspected Clinical Signs of InfectionS

NCT06058819 | Recruiting

• 1 other identifier: 69HCL23_0633
• Study Type: observational
• Target: 358
• Locations: 1 country
• Sites: 3

Brief Summary

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

Neonatal Late Onset Sepsis

Keywords

neonatal sepsis,; biomarker; diagnostic,; antibiotic use; preterm neonates; NICU

Outcome Measures

Primary Outcomes (1)

• Diagnosis of late onset sepsis

  The primary outcome measure will be determined by an independent adjudication committee that will classify the patients into the following categories : infection, non infected or undetermined. This committee will be blinded to the biomarkers of the study. It will be composed of two neonatologists and a pediatrician specialized in pediatric infectious diseases. The diagnostic performance of the biomarkers combination will be based on the adjudication committee classification (gold standard).

  72 hours maximum after inclusion

Interventions

Newborns suspected of Infections DIAGNOSTIC_TEST

This study will include NICU newborns of at least 7 days of life with suggestive signs of neonatal sepsis. The results will be extrapolated to this same population.

Eligibility Criteria

• Age: 7 Days - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborns aged ≥ 7 days hospitalized in one of the 2 neonatal intensive care units (Nantes or Lyon) for whom an infection is suspected.

You may qualify if:

• Patients aged ≥ 7 days
• Patients weighted ≥ 500 g the day of blood sample
• patients with suggestive signs of LOS including at least one of the following:Fever \> 38°C; 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 may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

neonatal Intensive care unit, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, France

Bron, 69500, France

RECRUITING

Hôpital Couple-Enfant - CHU Grenoble Alpes

Grenoble, 38700, France

RECRUITING

Neonatal intensive care unit, Hôpital femme-maternité

Nantes, 44300, France

RECRUITING

MeSH Terms

Conditions

Neonatal Sepsis; Disease

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marine BUTIN, Pr

CONTACT

+33 4 27 85 52 84; marine.butin@chu-lyon.fr

Sophie TROUILLET-ASSANT

CONTACT

+33 4 72 67 87 80; sophie.trouillet-assant@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: November 22, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)