NCT06058819 Validation of Biomarkers Performance to Reduce Antibiotics overUse in newBorns With Suspected Clinical Signs of InfectionS
| NCT ID | NCT06058819 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Neonatal Late Onset Sepsis |
| Study Type | OBSERVATIONAL |
| Enrollment | 358 participants |
| Start Date | 2023-11-22 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 358 participants in total. It began in 2023-11-22 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06058819 clinical trial?
This trial is open to participants of all sexes, aged 7 Days or older, up to 14 Days, studying Neonatal Late Onset Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06058819 currently recruiting?
Yes, NCT06058819 is actively recruiting participants. Contact the research team at marine.butin@chu-lyon.fr for enrollment information.
Where is the NCT06058819 trial being conducted?
This trial is being conducted at Bron, France, Grenoble, France, Nantes, France.
Who is sponsoring the NCT06058819 clinical trial?
NCT06058819 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 358 participants.