Validation of biomarkers to reduce antibiotic use in newborns with suspected infections
Validation of Biomarkers Performance to Reduce Antibiotics overUse in newBorns With Suspected Clinical Signs of InfectionS
This study is testing if certain biomarkers can help doctors better diagnose infections in newborns so they can use fewer antibiotics in the NICU.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 358 (estimated) |
| Ages | 7 Days to 14 Days |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 3 sites (Bron and 2 other locations) |
| Trial ID | NCT06058819 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the performance of specific biomarkers in diagnosing late-onset neonatal sepsis (LOS) in newborns aged 7 days or older. By identifying reliable biomarkers, the study seeks to reduce unnecessary antibiotic use in Neonatal Intensive Care Units (NICUs), which is currently prevalent due to the challenges in diagnosing LOS. The study will involve newborns suspected of infections and will assess clinical signs alongside standard blood sampling for biomarkers. The goal is to improve diagnostic accuracy and minimize the risks associated with excessive antibiotic treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are hospitalized newborns in NICUs who are at least 7 days old and show clinical signs suggestive of late-onset sepsis.
Not a fit: Patients who are currently being treated with antibiotics for a confirmed infection or have undergone surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce unnecessary antibiotic use in newborns, lowering the risk of antibiotic resistance and associated complications.
How similar studies have performed: Previous studies have explored biomarkers for diagnosing neonatal sepsis, but this specific approach to validate their performance in reducing antibiotic use is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bron and 2 other locations
- 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)
Study contacts
- Study coordinator: Marine BUTIN, Pr
- Email: marine.butin@chu-lyon.fr
- Phone: +33 4 27 85 52 84
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.