T6A Biomarker for Detection of Bacterial Infection in Newborn Infants (T6ASepsis)
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lorenz Stana-Hackenberg, MD
- Número de teléfono: +4357255-57757
- Correo electrónico: L.stana-hackenberg@salk.at
Ubicaciones de estudio
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Salzburg, Austria, 5020
- Reclutamiento
- Paracelsus Medical Private University- University Hospital Salzburg Dept. of Pediatrics and Adolescent Medicine, Division of Neonatology
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Contacto:
- Lorenz Stana-Hackenberg
- Número de teléfono: +4357255-57757
- Correo electrónico: l.stana-hackenberg@salk.at
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Sub-Investigador:
- Martin Wald, Assoc. Prof.
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Sub-Investigador:
- Maria Strasser, MD
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Sub-Investigador:
- Maren Doenhardt
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Investigador principal:
- Lorenz Stana-Hackenberg, MD
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Wroclaw, Polonia, 50367
- Aún no reclutando
- Wroclaw Medical University
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Contacto:
- Barbara Królak-Olejnik, Prof.
- Número de teléfono: +48 71 7331500
- Correo electrónico: barbara.krolak-olejnik@umw.edu.pl
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Investigador principal:
- Barbara Królak-Olejnik, Prof
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
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Control S
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Pacientes
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of participants with Clinical Sepsis
Periodo de tiempo: 12 Hours
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1. Clinical Sepsis (no pathogen detected): All of:
AND at least 2 of:
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12 Hours
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Number of participants with Microbiologically Confirmed Sepsis (excluding coagulase negative staphylococci CNS)
Periodo de tiempo: 12 Hours
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Microbiologically Confirmed Sepsis (excluding coagulase negative staphylococci CNS) AND at least 2 of:
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12 Hours
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Number of participants with Microbiologically confirmed Sepsis with CNS
Periodo de tiempo: 12 Hours
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Microbiologically confirmed sepsis with CNS as the sole pathogen One lab value (without other plausible cause)
AND at least 2 of:
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12 Hours
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Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
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Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- T6A_NewbornSepsis_V6
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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