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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03937245




Registration number
NCT03937245
Ethics application status
Date submitted
1/05/2019
Date registered
3/05/2019
Date last updated
9/09/2021

Titles & IDs
Public title
Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care
Scientific title
Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care: the Eurobact II Multinational Cohort Study
Secondary ID [1] 0 0
EurobactII
Universal Trial Number (UTN)
Trial acronym
EurobactII
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacteremia 0 0
Sepsis 0 0
Hospital Acquired Condition 0 0
Resistance Bacterial 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Blood 0 0 0 0
Other blood disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
HA-BSI - Patients with HA-BSI treated in an ICU
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
Progress of organ failures
Timepoint [1] 0 0
7 days
Secondary outcome [2] 0 0
Days free or organ supportive therapy
Timepoint [2] 0 0
28 days
Secondary outcome [3] 0 0
Clinical cure
Timepoint [3] 0 0
7 days, 28 days
Secondary outcome [4] 0 0
Microbiological cure
Timepoint [4] 0 0
7 days, 28 days

Eligibility
Key inclusion criteria
* Age > 18 Years.
* Hospital Acquired Bloodstream Infection (HA-BSI).
* Treated in the ICU.

* ICU acquired OR
* Hospital acquired prior to ICU admission
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/06/2021
Sample size
Target
Accrual to date
Final
3058
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Redcliffe Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4020 - Brisbane
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Paris

Funding & Sponsors
Primary sponsor type
Other
Name
Outcome Rea
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
European Society of Intensive Care Medicine
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
European Society of Clinical Microbiology and Infectious Diseases
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Institut National de la Santé Et de la Recherche Médicale, France
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT03937245
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Alexis Tabah, MD
Address 0 0
ICU, Redcliffe Hospital, Faculty of Medicine, UQ, Brisbane, QLD, Australia.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03937245