Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-24 @ 11:47 PM
NCT ID:
NCT03299751
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Days
Study:
NCT03299751
Study Brief:
Protocol Section:
NCT03299751