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NCT03937245 Clinical Trial

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

Sepsis Clinical Trial

— EurobactII  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03937245
Other study ID # EurobactII
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 30, 2019
Est. completion date June 3, 2021

Study information
Verified date September 2021
Source Outcome Rea
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 3058
Est. completion date June 3, 2021
Est. primary completion date June 2, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Australia Redcliffe Hospital Brisbane Queensland
France Reanimation Medicale et Infectieuse-Hopital Bichat Paris

Sponsors (4)
Lead Sponsor Collaborator
Outcome Rea 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

Countries where clinical trial is conducted

Australia,  France, 

References & Publications (1)

Tabah A, Koulenti D, Laupland K, Misset B, Valles J, Bruzzi de Carvalho F, Paiva JA, Cakar N, Ma X, Eggimann P, Antonelli M, Bonten MJ, Csomos A, Krueger WA, Mikstacki A, Lipman J, Depuydt P, Vesin A, Garrouste-Orgeas M, Zahar JR, Blot S, Carlet J, Brun-Buisson C, Martin C, Rello J, Dimopoulos G, Timsit JF. Characteristics and determinants of outcome of hospital-acquired bloodstream infections in intensive care units: the EUROBACT International Cohort Study. Intensive Care Med. 2012 Dec;38(12):1930-45. doi: 10.1007/s00134-012-2695-9. Epub 2012 Sep 26. — View Citation

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