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

NCT ID: NCT03937245

Last Updated: 2021-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3058 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-30

Study Completion Date

2021-06-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bacteremia Sepsis Hospital Acquired Condition Resistance Bacterial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HA-BSI

Patients with HA-BSI treated in an ICU

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

European Society of Intensive Care Medicine

OTHER

Sponsor Role collaborator

European Society of Clinical Microbiology and Infectious Diseases

OTHER

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Outcome Rea

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexis Tabah, MD

Role: PRINCIPAL_INVESTIGATOR

ICU, Redcliffe Hospital, Faculty of Medicine, UQ, Brisbane, QLD, Australia.

Jean-Francois Timsit, MD,PhD

Role: STUDY_DIRECTOR

Medical and infectious diseases ICU, Bichat hospital, IAME U 1137,Paris,France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Redcliffe Hospital

Brisbane, Queensland, Australia

Site Status

Reanimation Medicale et Infectieuse-Hopital Bichat

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23011531 (View on PubMed)

Gajdos L, Buetti N, Tabah A, Ruckly S, Akova M, Sjoval F, Arvaniti K, de Waele J, Bracht H, Barbier F, Timsit JF; EUROBACT-2 Study Group, the European Society of Intensive Care Medicine (ESICM), the European Society of Clinical Microbiology, the Infectious Diseases (ESCMID) Study Group for Infections in Critically Ill Patients (ESGCIP) and the OUTCOMEREA Network. Shortening antibiotic therapy duration for hospital-acquired bloodstream infections in critically ill patients: a causal inference model from the international EUROBACT-2 database. Intensive Care Med. 2025 Mar;51(3):518-528. doi: 10.1007/s00134-025-07857-6. Epub 2025 Apr 7.

Reference Type DERIVED
PMID: 40192823 (View on PubMed)

Buetti N, Tabah A, Loiodice A, Ruckly S, Aslan AT, Montrucchio G, Cortegiani A, Saltoglu N, Kayaaslan B, Aksoy F, Murat A, Akdogan O, Saracoglu KT, Erdogan C, Leone M, Ferrer R, Paiva JA, Hayashi Y, Ramanan M, Conway Morris A, Barbier F, Timsit JF; Eurobact 2 study group. Different epidemiology of bloodstream infections in COVID-19 compared to non-COVID-19 critically ill patients: a descriptive analysis of the Eurobact II study. Crit Care. 2022 Oct 18;26(1):319. doi: 10.1186/s13054-022-04166-y.

Reference Type DERIVED
PMID: 36258239 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

http://www.eurobact.org

Eurobact II website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EurobactII

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.