Validation of biomarkers to reduce antibiotic use in newborns with suspected infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.