Status:
COMPLETED
Evaluation of bioMarkErs to Reduce Antibiotics Use in hospitalizeD nEonates
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Late-Onset Neonatal Sepsis
Eligibility:
All Genders
7+ years
Phase:
NA
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 res...
Eligibility Criteria
Inclusion
- patients hospitalized in NICU;
- patients with suggestive signs of LOS including at least one of the following:
- o Fever \> 38°C; tachycardia \> 160bpm160 bpm; capillary refill time \> 3 seconds; grey and/or pale skin complexion; apnea/ bradycardia syndrome,; bloating; 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;
- patients with a standard of care blood sampling, including at least a blood culture;
- consent form signed by at least one parent/ legal representative.
Exclusion
- patients treated with antibiotics for a bacteriologically confirmed infection at the moment of/ or 48 hours before blood sampling
- patients who underwent surgery during the 7 days prior to inclusion
- patients vaccinated during the 7 days prior to inclusion
Key Trial Info
Start Date :
November 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2020
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT03299751
Start Date
November 22 2017
End Date
November 20 2020
Last Update
September 4 2025
Active Locations (2)
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1
Hospices Civils de Lyon
Bron, France, 69500
2
CHU de Nantes
Nantes, France