Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

T6A Biomarker for Detection of Bacterial Infection in Newborn Infants (T6ASepsis)

4. september 2026 opdateret af: Lorenz Auer-Hackenberg, Salzburger Landeskliniken
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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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.

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 bi-center study conducted at the Private Medical University of Salzburg, Austria together with the Medical University of Wrocław in cooperation with the Ludwig Boltzmann Institute for Traumatology, The Research Center in Cooperation with AUVA, Vienna 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 24 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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

210

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Polen
      • Wroclaw, Polen, 50367
        • Ikke rekrutterer endnu
        • Wroclaw Medical University
        • Kontakt:
        • Ledende efterforsker:
          • Barbara Królak-Olejnik, Prof
  • Østrig
      • Salzburg, Østrig, 5020
        • Rekruttering
        • Paracelsus Medical Private University- University Hospital Salzburg Dept. of Pediatrics and Adolescent Medicine, Division of Neonatology
        • Kontakt:
        • Underforsker:
          • Martin Wald, Assoc. Prof.
        • Underforsker:
          • Maria Strasser, MD
        • Underforsker:
          • Maren Doenhardt
        • Ledende efterforsker:
          • Lorenz Stana-Hackenberg, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Newborn infants

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Kontrolelementer
Patienter

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants with Clinical Sepsis
Tidsramme: 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)
12 Hours
Number of participants with Microbiologically Confirmed Sepsis (excluding coagulase negative staphylococci CNS)
Tidsramme: 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)
12 Hours
Number of participants with Microbiologically confirmed Sepsis with CNS
Tidsramme: 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)
12 Hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Salzburger Landeskliniken

Samarbejdspartnere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. september 2026

Primær færdiggørelse (Anslået)

31. januar 2029

Studieafslutning (Anslået)

31. januar 2029

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

25. juni 2026

Først opslået (Faktiske)

26. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. september 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • T6A_NewbornSepsis_V6

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner