European Prospective Bloodstream Infection Cohort

NCT07082322 | Not Yet Recruiting

• 1 other identifier: 24-1521-S1
• Study Type: observational
• Target: 40,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bloodstream Infection

Keywords

Registry; Therapeutical management

Outcome Measures

Primary Outcomes (2)

• Incidence of bloodstream infections

  Incidence of bloodstream infection patients stratified by pathogen

  5 years, analysed aggregated by year

• In hospital mortality

  Fraction of patients that died during hospital stay

  Hospital stay after infection onset until discharge, an average of 3 weeks

Secondary Outcomes (2)

• Patient-reported health quality

  Day 90 after onset

• Mortality at day 90

  Day 90

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients that are hospitalised with a blood culture-detected bloodstream infection are eligible for inclusion into this study.

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Freiburg: lead

Study Sites (1)

University Hospital Freiburg

Freiburg im Breisgau, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Microbiological isolates

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Siegbert Rieg, Prof. Dr.

  University Hospital Freiburg

  PRINCIPAL INVESTIGATOR

• Philipp Mathé, Dr.

  University Hospital Freiburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siegbert Rieg, Prof. Dr.

CONTACT

+49 761 270 18190; siegbert.rieg@uniklinik-freiburg.de

Philipp Mathé, Dr.

CONTACT

+49 761 270 18190; philipp.mathe@uniklinik-freiburg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Siegbert Rieg/Dr. Philipp Mathé

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)