Bloodstream InfectionEPIC-BSINCT07082322
European Prospective Bloodstream Infection Cohort
An observational study of Bloodstream Infection, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
Background: Bloodstream infections (BSIs) and sepsis continue to pose significant public health challenges, contributing to high morbidity and mortality worldwide. According to the Global Burden of Diseases Study, BSIs and sepsis are associated with approximately 20% of global deaths. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bloodstream Infection
- How many people
- 40,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2025to 1 Jan 2031
- How long will I take part?
- 90 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that are hospitalised with a blood culture-detected bloodstream infection are eligible for inclusion into this study.
Who may be able to join
- EPIC-BSI Registry: Positive blood cultures result. For each patient only the first positive blood culture result during 90 days would be counted.
- EPIC-BSI Diagnostic study: Centre recruiting for the EPIC study with access to microbiological and clinical data.
- EPIC-BSI Management study - Regular dataset: First two BSI cases per month of (at least two or three) target pathogens (S. aureus, E. faecalis/E. faecium, E. coli, Klebsiella spp., P. aeruginosa, A. baumanii, Streptococcus spp.)
Who cannot join
- EPIC-BSI Registry: Non-comprehensive documentation and reporting of BSI cases, Age < 18 years
- EPIC-BSI Diagnostic Study: EPIC BSI centre does not participate in the EPIC BSI Diagnostic Study arm
- EPIC-BSI Management Study: Non-comprehensive documentation and reporting of BSI cases; Age < 18 years; For Follow-up part: Patient with dementia or other progressed neurological or vigilance disorder without contact details of legal representative, which makes follow-up unfeasible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University Hospital Freiburg
Freiburg im Breisgau
Siegbert Rieg, +49 761 270 18190, siegbert.rieg@uniklinik-freiburg.de
Philipp Mathé, + 49 761 270 18190, philipp.mathe@uniklinik-freiburg.de
About this study
Background:
Bloodstream infections (BSIs) and sepsis continue to pose significant public health challenges, contributing to high morbidity and mortality worldwide. According to the Global Burden of Diseases Study, BSIs and sepsis are associated with approximately 20% of global deaths. However, the clinical characteristics of BSIs have evolved over recent years, showing significant variability across different countries and continents. The diversity in management standards across regions further complicates the generalization and transferability of research findings. Despite the critical need for comprehensive data, BSI research in Europe remains fragmented, often limited to national-level studies.
Read more
Project Aim:
The EPIC-BSI project aims to address these challenges by establishing a multinational, collaborative bloodstream infection cohort across Europe and globally. The primary objectives are to:
- Integrate national BSI research into a cohesive multinational cohort that enable large-scale comparative research by standardizing BSI incidence data, diagnostic and therapeutic approaches, and patient outcomes across European countries and beyond.
- Monitor shifts in BSI characteristics, including the emergence of multi-drug resistant organisms, and changes in risk groups, diagnostics, and therapies.
- Create a foundation for future studies and collaborations, such as integrating BSI data with international antibiotic usage, population data, health policy data, or by biobanking blood-borne pathogens for sequencing.
The study is divided into three arms focusing on BSI epidemiology (EPIC-BSI registry), diagnostics (EPIC-BSI Diagnostic Study) and management (EPIC-BSI Management study). The EPIC-BSI Management study is partitioned in different levels of data contribution to reduce barriers for centres and enable broad participation.
Specific Objectives and Endpoints:
EPIC-BSI Registry:
- Primary aim/endpoint: Establish an international prospective BSI cohort with anonymized inclusion of all BSI cases from participating centres allowing estimation of BSI incidence by pathogen in the participating centres.
- Secondary aims/endpoints:
- Analyse the incidence of BSIs across different settings and countries.
- Monitor changes in patient demographics (age, gender) and acquisition modes.
- Track shifts in antimicrobial resistance patterns.
- Review effects of infection control practices on MDRO-BSI frequency
EPIC-BSI Diagnostic Study:
- Primary aim/endpoint: Biannual evaluation of diagnostic procedures and standards regarding BSI at participating centres
- Secondary aims/endpoints:
- Assess the availability and use of (new) clinical and microbiological diagnostics.
- Identify gaps in diagnostic practices and time lags between scientific evidence, guideline publication and clinical implementation of new diagnostic utilities.
EPIC-BSI Management Study:
- Primary aim/endpoint: Analyse clinical data from BSI cases to evaluate management practices regarding the effect on in-hospital mortality and outcome on day 90 after onset incl. patient-reported outcomes (Desirability-of-outcome-ranking (DOOR) or health-related quality of life metrics)
- Secondary aims/endpoints:
- Identify differences in clinical management across countries and hospital types.
- Analyse the impact of antimicrobial resistance patterns on clinical outcomes.
- Evaluate the effectiveness of different established therapeutic regimens.
- Conditions
- Bloodstream Infection
- Keywords
- Registry, Therapeutical management
- Medical subject headings
- 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 |
|---|---|---|
| EPIC BSI Registry | Registry of bloodstream infection patients from microbiological databases | |
| EPIC BSI Diagnostics | Repeated survey of participating centers regarding their diagnostic standard of care | |
| EPIC BSI Management | Registry of bloodstream infection patients with focus on clinical course and management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bloodstream infections
Incidence of bloodstream infection patients stratified by pathogen
Measured: 5 years, analysed aggregated by year
In hospital mortality
Fraction of patients that died during hospital stay
Measured: Hospital stay after infection onset until discharge, an average of 3 weeks
Secondary outcomes (2)
Patient-reported health quality
Patient reported health-related quality of life at day 90 measured by the EQ-5D-5L (European Quality of Life 5 Dimensions 5 Level Version) questionaire ranging between 0 (very bad) to very good (1)
Measured: Day 90 after onset
Mortality at day 90
Overall and infection-attributable mortality at day 90 after onset
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bloodstream InfectionStudies 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
- 40,000 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Mathe, University Hospital Freiburg
- Investigators
- Siegbert Rieg, Prof. Dr., Principal investigator, University Hospital FreiburgPhilipp Mathé, Dr., Principal investigator, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082322
- Sponsor's protocol ID
- 24-1521-S1
- Acronym
- EPIC-BSI
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data analyses and publications are carried out with anonymized data, so that no conclusions can be drawn about the respective patients. At the end of the study, the anonymised data will be saved in a corresponding database for fur- ther scientific use by other research groups upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Prospective Bloodstream Infection Cohort
- ClinicalTrials.gov ID
- NCT07082322
- Acronym / sponsor ID
- EPIC-BSI / 24-1521-S1
- Conditions
- Bloodstream Infection
- Keywords
- Registry, Therapeutical management
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 24 Jul 2025 (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.
Background:
Bloodstream infections (BSIs) and sepsis continue to pose significant public health challenges, contributing to high morbidity and mortality worldwide. According to the Global Burden of Diseases Study, BSIs and sepsis are associated with approximately 20% of global deaths. However, the clinical characteristics of BSIs have evolved over recent years, showing significant variability across different countries and continents. The diversity in management standards across regions further complicates the generalization and transferability of research findings. Despite the critical need for comprehensive data, BSI research in Europe remains fragmented, often limited to national-level studies.
Project Aim:
The EPIC-BSI project aims to address these challenges by establishing a multinational, collaborative bloodstream infection cohort across Europe and globally. The primary objectives are to:
- Integrate national BSI research into a cohesive multinational cohort that enable large-scale comparative research by standardizing BSI incidence data, diagnostic and therapeutic approaches, and patient outcomes across European countries and beyond.
- Monitor shifts in BSI characteristics, including the emergence of multi-drug resistant organisms, and changes in risk groups, diagnostics, and therapies.
- Create a foundation for future studies and collaborations, such as integrating BSI data with international antibiotic usage, population data, health policy data, or by biobanking blood-borne pathogens for sequencing.
The study is divided into three arms focusing on BSI epidemiology (EPIC-BSI registry), diagnostics (EPIC-BSI Diagnostic Study) and management (EPIC-BSI Management study). The EPIC-BSI Management study is partitioned in different levels of data contribution to reduce barriers for centres and enable broad participation.
Specific Objectives and Endpoints:
EPIC-BSI Registry:
- Primary aim/endpoint: Establish an international prospective BSI cohort with anonymized inclusion of all BSI cases from participating centres allowing estimation of BSI incidence by pathogen in the participating centres.
- Secondary aims/endpoints:
- Analyse the incidence of BSIs across different settings and countries.
- Monitor changes in patient demographics (age, gender) and acquisition modes.
- Track shifts in antimicrobial resistance patterns.
- Review effects of infection control practices on MDRO-BSI frequency
EPIC-BSI Diagnostic Study:
- Primary aim/endpoint: Biannual evaluation of diagnostic procedures and standards regarding BSI at participating centres
- Secondary aims/endpoints:
- Assess the availability and use of (new) clinical and microbiological diagnostics.
- Identify gaps in diagnostic practices and time lags between scientific evidence, guideline publication and clinical implementation of new diagnostic utilities.
EPIC-BSI Management Study:
- Primary aim/endpoint: Analyse clinical data from BSI cases to evaluate management practices regarding the effect on in-hospital mortality and outcome on day 90 after onset incl. patient-reported outcomes (Desirability-of-outcome-ranking (DOOR) or health-related quality of life metrics)
- Secondary aims/endpoints:
- Identify differences in clinical management across countries and hospital types.
- Analyse the impact of antimicrobial resistance patterns on clinical outcomes.
- Evaluate the effectiveness of different established therapeutic regimens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EPIC BSI Registry | – | –Registry of bloodstream infection patients from microbiological databases |
| EPIC BSI Diagnostics | – | –Repeated survey of participating centers regarding their diagnostic standard of care |
| EPIC BSI Management | – | –Registry of bloodstream infection patients with focus on clinical course and management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that are hospitalised with a blood culture-detected bloodstream infection are eligible for inclusion into this study.
Key inclusion criteria (3 listed)
- EPIC-BSI Registry: Positive blood cultures result. For each patient only the first positive blood culture result during 90 days would be counted.
- EPIC-BSI Diagnostic study: Centre recruiting for the EPIC study with access to microbiological and clinical data.
- EPIC-BSI Management study - Regular dataset: First two BSI cases per month of (at least two or three) target pathogens (S. aureus, E. faecalis/E. faecium, E. coli, Klebsiella spp., P. aeruginosa, A. baumanii, Streptococcus spp.)
Key exclusion criteria (3 listed)
- EPIC-BSI Registry: Non-comprehensive documentation and reporting of BSI cases, Age < 18 years
- EPIC-BSI Diagnostic Study: EPIC BSI centre does not participate in the EPIC BSI Diagnostic Study arm
- EPIC-BSI Management Study: Non-comprehensive documentation and reporting of BSI cases; Age < 18 years; For Follow-up part: Patient with dementia or other progressed neurological or vigilance disorder without contact details of legal representative, which makes follow-up unfeasible
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
Incidence of bloodstream infections
Time frame: 5 years, analysed aggregated by year
Incidence of bloodstream infection patients stratified by pathogen
In hospital mortality
Time frame: Hospital stay after infection onset until discharge, an average of 3 weeks
Fraction of patients that died during hospital stay
2 secondary outcomes
Patient-reported health quality
Time frame: Day 90 after onset
Mortality at day 90
Time frame: Day 90
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 24 Jul 2025.
- Individual participant dataSharing planned: Yes. All data analyses and publications are carried out with anonymized data, so that no conclusions can be drawn about the respective patients. At the end of the study, the anonymised data will be saved in a corresponding database for fur- ther scientific use by other research groups upon reasonable request.
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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.
Siegbert Rieg, Prof. Dr. principal investigator
University Hospital Freiburg
Philipp Mathé, Dr. principal investigator
University Hospital Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bloodstream Infection, run by University Hospital Freiburg at 1 site in Germany.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 Siegbert Rieg, Prof. Dr. (+49 761 270 18190, siegbert.rieg@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bloodstream infections (time frame: 5 years, analysed aggregated by year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2025.