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T6A Biomarker for Detection of Bacterial Infection in Newborn Infants

ConditionsSepsisNewborn SepsisBiomarker Discovery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSalzburger Landeskliniken

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Newborn infants who require blood testing for screening for bacterial infection OR treating physician suspects bacterial infection in newborn infant

Signed informed consent form

Disqualifiers

Refusal to participate in study or not providing written informed consent by caregivers/parents

Antibiotic treatment of any kind.

Trial population

Newborn infants

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

210 Participants
are grouped into 2 trial groups
Group A: Patients
Group B: Controls

Trial outcomes

Primary outcomes

1

Number of participants with Clinical Sepsis

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)

Time frame
12 Hours
2

Number of participants with Microbiologically Confirmed Sepsis (excluding coagulase negative staphylococci CNS)

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)

Time frame
12 Hours
3

Number of participants with Microbiologically confirmed Sepsis with CNS

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)

Time frame
12 Hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Salzburger Landeskliniken

Lead sponsor

Wroclaw Medical University

Collaborator

Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA

Collaborator

Source ClinicalTrials.gov
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