SepsisT6ASepsisNCT07670624
T6A Biomarker for Detection of Bacterial Infection in Newborn Infants
An observational study of Sepsis and Newborn Sepsis, run by Salzburger Landeskliniken at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis, Newborn Sepsis, Biomarker Discovery
- How many people
- 210 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Sep 2026to 31 Jan 2029
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Newborn infants
Who may be able to join
- Newborn infants who require blood testing for screening for bacterial infection OR treating physician suspects bacterial infection in newborn infant
- Signed informed consent form
Who cannot join
- Refusal to participate in study or not providing written informed consent by caregivers/parents
- Antibiotic treatment of any kind.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Austria1 site, 1 recruiting
- Recruiting
Paracelsus Medical Private University- University Hospital Salzburg Dept. of Pediatrics and Adolescent Medicine, Division of Neonatology
Salzburg, 5020
Lorenz Stana-Hackenberg, +4357255-57757, l.stana-hackenberg@salk.at
Martin Wald, Assoc. Prof.
Poland1 site, 1 recruiting
- Not yet recruiting
Wroclaw Medical University
Wroclaw, 50367
Barbara Królak-Olejnik, Prof., +48 71 7331500, barbara.krolak-olejnik@umw.edu.pl
Barbara Królak-Olejnik, Prof
About this study
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.
Read the detailed description
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.
- Conditions
- Sepsis, Newborn Sepsis, Biomarker Discovery
- Keywords
- t6a, newborn sepsis, infectious disease biomarker, biomarker
- Medical subject headings
- Sepsis, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described | |
| Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Clinical Sepsis
- 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)
Measured: 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)
Measured: 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)
Measured: 12 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start3 Sep 2026
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Salzburger Landeskliniken
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University, Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
- Responsible party
- Principal investigator, Lorenz Auer-Hackenberg, Salzburger Landeskliniken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670624
- Sponsor's protocol ID
- T6A_NewbornSepsis_V6
- Acronym
- T6ASepsis
- Status last verified
- Aug 2026
- First submitted
- 2 Jun 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38889701Osuchowski 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.
PubMed 40114270Zhou 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.
PubMed 25996378Al 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.
PubMed 36513805
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T6A Biomarker for Detection of Bacterial Infection in Newborn Infants
- ClinicalTrials.gov ID
- NCT07670624
- Acronym / sponsor ID
- T6ASepsis / T6A_NewbornSepsis_V6
- Conditions
- Sepsis, Newborn Sepsis, Biomarker Discovery
- Keywords
- t6a, newborn sepsis, infectious disease biomarker, biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Salzburger LandesklinikenUniversity, hospital or other
- Collaborators
- Wroclaw Medical University, Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | – |
| Controls | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newborn infants
Key inclusion criteria (2 listed)
- Newborn infants who require blood testing for screening for bacterial infection OR treating physician suspects bacterial infection in newborn infant
- Signed informed consent form
Key exclusion criteria (2 listed)
- Refusal to participate in study or not providing written informed consent by caregivers/parents
- Antibiotic treatment of any kind.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with Clinical Sepsis
Time frame: 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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 38889701Mackay 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.
- Background: PubMed 40114270Osuchowski 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.
- Background: PubMed 25996378Zhou 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.
- Background: PubMed 36513805Al 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Newborn Sepsis, run by Salzburger Landeskliniken at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenz Stana-Hackenberg, MD (+4357255-57757, L.stana-hackenberg@salk.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Clinical Sepsis (time frame: 12 Hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07670624, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.