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

September 8, 2021 updated by: Outcome Rea

Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care: the Eurobact II Multinational Cohort Study

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

3058

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4020
        • Redcliffe Hospital
  • France
      • Paris, France, 75018
        • Reanimation Medicale et Infectieuse-Hopital Bichat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a HA-BSI treated in an ICU

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HA-BSI
Patients with HA-BSI treated in an ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 28 days
Vital status
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Outcome Rea

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
European Society of Intensive Care Medicine
European Society of Clinical Microbiology and Infectious Diseases

Investigators

  • Principal Investigator: Alexis Tabah, MD, ICU, Redcliffe Hospital, Faculty of Medicine, UQ, Brisbane, QLD, Australia.
  • Study Director: Jean-Francois Timsit, MD,PhD, Medical and infectious diseases ICU, Bichat hospital, IAME U 1137,Paris,France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 30, 2019

Primary Completion (ACTUAL)

June 2, 2021

Study Completion (ACTUAL)

June 3, 2021

Study Registration Dates

First Submitted

May 1, 2019

First Submitted That Met QC Criteria

May 2, 2019

First Posted (ACTUAL)

May 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EurobactII

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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