NCT03937245

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,058

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

August 30, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2021

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

1.8 years

First QC Date

May 1, 2019

Last Update Submit

September 8, 2021

Conditions

BacteremiaSepsisHospital Acquired ConditionResistance Bacterial

Keywords

Hospital-acquired infectionBlood stream infectionBacteremiaIntensive care

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Vital status

    28 days

Secondary Outcomes (4)

  • Progress of organ failures

    7 days

  • Days free or organ supportive therapy

    28 days

  • Clinical cure

    7 days, 28 days

  • Microbiological cure

    7 days, 28 days

Study Arms (1)

HA-BSI

Patients with HA-BSI treated in an ICU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a HA-BSI treated in an ICU

You may qualify if:

  • Age \> 18 Years.
  • Hospital Acquired Bloodstream Infection (HA-BSI).
  • Treated in the ICU.
  • ICU acquired OR
  • Hospital acquired prior to ICU admission

You may not qualify if:

  • 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.
  • HA-BSI is defined as a positive blood culture (BC) sampled after 48 hours following hospital admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Redcliffe Hospital

Brisbane, Queensland, 4020, Australia

Location

Reanimation Medicale et Infectieuse-Hopital Bichat

Paris, 75018, France

Location

Related Publications (3)

  • 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.

    PMID: 23011531BACKGROUND

  • 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.

    PMID: 40192823DERIVED

  • 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.

    PMID: 36258239DERIVED

Related Links

MeSH Terms

Conditions

BacteremiaSepsisIatrogenic DiseaseCross Infection

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Alexis Tabah, MD

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

    PRINCIPAL INVESTIGATOR

  • Jean-Francois Timsit, MD,PhD

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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2019

First Posted

May 3, 2019

Study Start

August 30, 2019

Primary Completion

June 2, 2021

Study Completion

June 3, 2021

Last Updated

September 9, 2021

Record last verified: 2021-09

Locations

AU(1)FR(1)