Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care

Completed

• Conditions: Bacteremia; Resistance Bacterial; Sepsis; Hospital Acquired Condition

• Registration Number: NCT03937245
• Lead Sponsor: Outcome Rea

Brief Summary

Eurobact II will investigate the mortality and morbidity of hospital-acquired blood stream infections in patients treated in intensive care units (ICU). It will investigate the effects of the micro-organism and its characteristics, such as type and resistance to antibiotics on the infection and its consequences. It will also investigate the effects of the antibiotics and other treatments on survival of patients. Eurobact II will include patients from multiple ICUs in multiple countries.

Detailed Description

Eurobact II is a multinational multicentre cohort study that will include patients with hospital-acquired blood stream infections (HA-BSI) treated in ICUs around the globe. It will provide with an update of the epidemiology of HA-BSI since the Eurobact I study. It is designed to investigate the effects of HA-BSI on mortality at day 28. To describe the determinants of outcomes of HA-BSI, specifically the effects of the source of infection, the microorganism, the characteristics of antimicrobial therapy and of source control. It will investigate patient specific and organizational factors and will describe the determinants of management of HA-BSI in ICUs.

Study Timeline

• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-03
• Study Start: 2019-08-30
• Primary Completion: 2021-06-02
• Study Completion: 2021-06-03
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3058

Inclusion Criteria

• Age > 18 Years.

• Hospital Acquired Bloodstream Infection (HA-BSI).

• Treated in the ICU.

  • ICU acquired OR
  • Hospital acquired prior to ICU admission

Exclusion Criteria

• Patients that had a positive blood culture in the hospital and transferred to ICU for a different reason than specific treatment of the causes or consequences of HA-BSI.

• Previous inclusion in the study.

  • HA-BSI is defined as a positive blood culture (BC) sampled after 48 hours following hospital admission.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	28 days	Vital status

Secondary Outcome Measures

Name	Time	Method
Clinical cure	7 days, 28 days	As evaluated by the treating clinician
Days free or organ supportive therapy	28 days	Days free of renal replacement therapy, mechanical ventilation, vasopressors, intensive care unit
Microbiological cure	7 days, 28 days	Presence of persisting or relapsing blood stream infection
Progress of organ failures	7 days	Assessed by the components of the SOFA score

Trial Locations

Locations (2)

Redcliffe Hospital; 🇦🇺 Brisbane, Queensland, Australia

Reanimation Medicale et Infectieuse-Hopital Bichat; 🇫🇷 Paris, France