This bi-center study aims to assess the efficacy of a new biomarker, N6-threonylcarbamoyladenosine (t6A), for the early diagnosis of Early-Onset Sepsis (EOS) in newborns.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Newborn infants who require blood testing for screening for bacterial infection OR treating physician suspects bacterial infection in newborn infant
* Signed informed consent form
Exclusion Criteria:
1. Refusal to participate in study or not providing written informed consent by caregivers/parents
2. Antibiotic treatment of any kind.
Primary outcome measure(s)
Number of participants with Clinical Sepsis — 12 Hours 1\. Clinical Sepsis (no pathogen detected):
All of:
* Initiation of adequate antimicrobial therapy ≥5 days by attending physician
* No pathogen detected in blood culture or not tested
* No clear infection elsewhere
AND at least 2 of:
* Fever (\>38°C) or temperature instability or hypothermia (\<36.5°C)
* Tachycardia (\>200/min) or new/increased bradycardia (\<80/min)
* Capillary refill \>2s
* New/increased apnoea (\>20 s)
* Unexplained metabolic acidosis (BE \< -10 mval/l)
* New onset hyperglycaemia (\>140 mg/dl)
* Other sepsis signs (skin color, abnormal labs, increased oxygen demand, unstable status, apathy)
Number of participants with Microbiologically Confirmed Sepsis (excluding coagulase negative staphylococci CNS) — 12 Hours Microbiologically Confirmed Sepsis (excluding coagulase negative staphylococci CNS)
AND at least 2 of:
* Fever (\>38°C) or temperature instability or hypothermia (\<36.5°C)
* Tachycardia (\>200/min) or new/increased bradycardia (\<80/min)
* Capillary refill \>2s
* New/increased apnoea (\>20 s)
* Unexplained metabolic acidosis (BE \< -10 mval/l)
* New onset hyperglycaemia (\>140 mg/dl)
* Other sepsis signs (skin color, abnormal labs, increased oxygen demand, unstable status, apathy)
Number of participants with Microbiologically confirmed Sepsis with CNS — 12 Hours Microbiologically confirmed sepsis with CNS as the sole pathogen One lab value (without other plausible cause)
* CRP \>2mg/dl
* I/T ratio \> 0.2
* Platelets \<100/nl
* Leukocytes \<5/nl
AND at least 2 of:
* Fever (\>38°C) or temperature instability or hypothermia (\<36.5°C)
* Tachycardia (\>200/min) or new/increased bradycardia (\<80/min)
* Capillary refill \>2s
* New/increased apnoea (\>20 s)
* Unexplained metabolic acidosis (BE \< -10 mval/l)
* New onset hyperglycaemia (\>140 mg/dl)
* Other sepsis signs (skin color, abnormal labs, increased oxygen demand, unstable status, apathy)
Trial sites (2)
Facility
City
Region
Status
Paracelsus Medical Private University- University Hospital Salzburg Dept. of Pediatrics and Adolescent Medicine, Division of Neonatology
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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