T6A Biomarker for Detection of Bacterial Infection in Newborn Infants

NCT07670624 | Not Yet Recruiting

• 1 other identifier: T6A_NewbornSepsis_V6
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis; Newborn Sepsis; Biomarker Discovery

Keywords

t6a; newborn sepsis; infectious disease biomarker; biomarker

Outcome Measures

Primary Outcomes (3)

• 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)

  12 Hours

• 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)

  12 Hours

• 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)

  12 Hours

Study Arms (2)

Patients

Controls

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Newborn infants

You may qualify if:

• Newborn infants who require blood testing for screening for bacterial infection OR treating physician suspects bacterial infection in newborn infant
• Signed informed consent form

You may not qualify if:

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

Sponsors & Collaborators

• Ludwig Boltzmann Gesellschaft: collaborator
• Salzburger Landeskliniken: lead
• Wroclaw Medical University: collaborator

Study Sites (1)

Wroclaw Medical University

Wroclaw, 50367, Poland

Location

Related Publications (4)

• Mackay CA, Nathan EA, Porter MC, Shrestha D, Kohan R, Strunk T. Epidemiology and Outcomes of Neonatal Sepsis: Experience from a Tertiary Australian NICU. Neonatology. 2024;121(6):703-714. doi: 10.1159/000539174. Epub 2024 Jun 18.

  PMID: 38889701 BACKGROUND

• Osuchowski MF, Adamik B, Gozdzik W, Skalec T, Mascher D, Redl H, Zipperle J, Fritsch G, Voelckel W, Winkler MS, Moerer O, Schutz H, Mascher H. The novel biomarker t6A accurately identified septic patients at admission but failed to predict outcome. Crit Care. 2025 Mar 20;29(1):129. doi: 10.1186/s13054-025-05354-2. No abstract available.

  PMID: 40114270 BACKGROUND

• Zhou M, Cheng S, Yu J, Lu Q. Interleukin-8 for diagnosis of neonatal sepsis: a meta-analysis. PLoS One. 2015 May 21;10(5):e0127170. doi: 10.1371/journal.pone.0127170. eCollection 2015.

  PMID: 25996378 BACKGROUND

• Al Gharaibeh FN, Lahni P, Alder MN, Wong HR. Biomarkers estimating baseline mortality risk for neonatal sepsis: nPERSEVERE: neonate-specific sepsis biomarker risk model. Pediatr Res. 2023 Oct;94(4):1451-1456. doi: 10.1038/s41390-022-02414-z. Epub 2022 Dec 13.

  PMID: 36513805 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole Blood samples

MeSH Terms

Conditions

Sepsis; Neonatal Sepsis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lorenz Stana-Hackenberg, MD

CONTACT

+4357255-57757; L.stana-hackenberg@salk.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 26, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)