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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06058819

Collaborator

(none)

358

Enrollment

Locations

Anticipated Duration (Months)

179

Patients Per Site

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neonatal Late Onset Sepsis	Diagnostic Test: Newborns suspected of Infections

Study Design

Study Type:

Observational

Anticipated Enrollment :

358 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Apr 1, 2026

Outcome Measures

Primary Outcome Measures

Diagnosis of late onset sepsis [72 hours maximum after inclusion]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Days to 14 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient hospitalized in the NICU of one of the two recruiting centers at the time of inclusion
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;

Exclusion Criteria:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	neonatal Intensive care unit, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, France	Bron		France	69500
2	Neonatal intensive care unit, Hôpital femme-maternité	Nantes		France	44300