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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bacteremia, Sepsis, Hospital Acquired Condition, Resistance Bacterial

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HA-BSI<br>Patients with HA-BSI treated in an ICU | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Vital status | 28 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hospital-acquired infection, Blood stream infection, Bacteremia, Intensive care