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NCT Number: NCT07670624

T6A Biomarker for Detection of Bacterial Infection in Newborn Infants

This study aims to assess the efficacy of a new biomarker, N6-threonylcarbamoyladenosine (t6A), for the early diagnosis of Early-Onset Sepsis (EOS) in newborns.

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Key information

Conditions

Sepsis Biomarker Discovery Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infections Inflammation Neonatal Sepsis Newborn Sepsis Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This study aims to assess the efficacy of a new biomarker, N6-threonylcarbamoyladenosine (t6A), for the early diagnosis of Early-Onset Sepsis (EOS) in newborns.

Background:

EOS is a significant concern for newborns, especially preterm infants, with a high mortality rate. Current diagnostic methods, like blood cultures, have limitations due to non-specific clinical presentations and slow turnaround times. Existing biomarkers such as C-reactive protein (CRP), procalcitonin (PCT), and Interleukin-6 (IL-6) also have limitations in terms of early detection and specificity.

Objective:

To facilitate the early diagnosis of EOS in newborns at risk for bacterial infection on day one.

Hypotheses:

t6A levels will rapidly increase in newborns with suspected EOS, allowing for early and precise identification from non-EOS neonates.

Circulating t6A will demonstrate higher diagnostic accuracy (positive and negative predictive values) compared to existing biomarkers like PCT, CRP, and IL-6.

Methodology:

This will be an open-label prospective cohort study conducted at the Private Medical University of Salzburg, Austria.

Study Population: Newborn infants requiring blood testing for suspected bacterial infection or routine screening who meet specific inclusion criteria and whose caregivers provide informed consent. Exclusion criteria include refusal to participate or current antibiotic treatment.

Control Group: 50 healthy newborn infants undergoing routine blood testing for other reasons (e.g., thyroid hormone testing).

Data Collection: Blood samples (20 µl using Neoteryx® Microsampling kit) will be collected via heel prick during routine patient care within the first 12 hours of life. Clinical and blood value data will also be collected. Samples will be analyzed for t6A, CBC, CRP, PCT, and IL-6.

Sepsis Confirmation: Bacterial infection will be confirmed using adapted NEO-KISS criteria, which include clinical sepsis and microbiologically confirmed sepsis (with and without coagulase-negative staphylococci).

Timeline: Patient enrollment will occur between February 1, 2026, and January 31, 2029.

Sample Size: A minimum of 210 participants (105 sepsis, 105 control) is planned to achieve adequate statistical power, based on AUC values of t6A and PCT from a previous study.

Data Management: Patient data will be anonymized with three-digit identification numbers. Blood samples will be sent to Pharm-analyt for testing.

Analysis/Statistics: Data will be analyzed using R. Primary outcome (differences in t6A levels) will be assessed using t-tests or Wilcoxon tests. Secondary outcomes (comparison of AUCs for t6A vs. IL-6 and CRP) will use DeLong's test with Bonferroni-Holms correction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Refusal to participate in study or not providing written informed consent by caregivers/parents
  • Antibiotic treatment of any kind.

Treatment and study plan

Primary outcomes

  1. Number of participants with Clinical Sepsis

    Time frame: 12 Hours

    • 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)

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

    Time frame: 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)

  3. Number of participants with Microbiologically confirmed Sepsis with CNS

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Lorenz Stana-Hackenberg, MD

CONTACT

[email protected]

+4357255-57757

Sponsors and collaborators

Lead sponsor

Salzburger Landeskliniken

Other

Collaborators

  • Ludwig Boltzmann Gesellschaft
  • Wroclaw Medical University

Registry information

Acronym: T6ASepsis

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 26, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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