An observational study in Sepsis, Newborn Sepsis and Biomarker Discovery, sponsored by Salzburger Landeskliniken. Recruiting at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Salzburger Landeskliniken · Observational
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.
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 210 is above the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →Salzburger Landeskliniken is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Newborn infants
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Plan to share: No
Started Sep 2026 (actual). Primary completion is estimated for Jan 2029, 28 months after the start.
Of 491 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's planned 28 months is close to that.
Counting every sponsor, half of 543 studies reached it within 27 months; a quarter within 12 and three quarters within 56.
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Salzburger Landeskliniken