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NCT Number: NCT03937245

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

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.

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Key information

Conditions

Bacteremia Bacterial Infections Bacterial Infections and Mycoses Cross Infection Disease Attributes Hospital Acquired Condition Iatrogenic Disease Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Resistance Bacterial Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Redcliffe Hospital, Brisbane, Queensland, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 28 days

    Vital status

Secondary outcomes

  1. Progress of organ failures

    Time frame: 7 days

    Assessed by the components of the SOFA score

  2. Days free or organ supportive therapy

    Time frame: 28 days

    Days free of renal replacement therapy, mechanical ventilation, vasopressors, intensive care unit

  3. Clinical cure

    Time frame: 7 days, 28 days

    As evaluated by the treating clinician

  4. Microbiological cure

    Time frame: 7 days, 28 days

    Presence of persisting or relapsing blood stream infection

Sponsors and collaborators

Lead sponsor

Outcome Rea

Other

Collaborators

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

Registry information

Official study title

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

Acronym: EurobactII

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 3, 2019
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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