BacteremiaEurobactIINCT03937245
Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care
An observational study of Bacteremia and Sepsis, run by Outcome Rea at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia, Sepsis, Hospital Acquired Condition
- How many people
- 3,058 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Aug 2019to 3 Jun 2021
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a HA-BSI treated in an ICU
Who may be able to join
- Age > 18 Years.
- Hospital Acquired Bloodstream Infection (HA-BSI).
- Treated in the ICU.
- ICU acquired OR
- Hospital acquired prior to ICU admission
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care: the Eurobact II Multinational Cohort Study
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.
Read the detailed 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.
- Conditions
- Bacteremia, Sepsis, Hospital Acquired Condition, Resistance Bacterial
- Keywords
- Hospital-acquired infection, Blood stream infection, Bacteremia, Intensive care
- Medical subject headings
- Bacteremia, Sepsis, Iatrogenic Disease, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HA-BSI | Patients with HA-BSI treated in an ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Vital status
Measured: 28 days
Secondary outcomes (4)
Progress of organ failures
Assessed by the components of the SOFA score
Measured: 7 days
Days free or organ supportive therapy
Days free of renal replacement therapy, mechanical ventilation, vasopressors, intensive care unit
Measured: 28 days
Clinical cure
As evaluated by the treating clinician
Measured: 7 days, 28 days
Microbiological cure
Presence of persisting or relapsing blood stream infection
Measured: 7 days, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start30 Aug 2019
- Primary completion2 Jun 2021
- Study completion3 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,058 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Outcome Rea
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine, European Society of Clinical Microbiology and Infectious Diseases, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Alexis Tabah, MD, Principal investigator, ICU, Redcliffe Hospital, Faculty of Medicine, UQ, Brisbane, QLD, Australia.Jean-Francois Timsit, MD,PhD, Study director, Medical and infectious diseases ICU, Bichat hospital, IAME U 1137,Paris,France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937245
- Sponsor's protocol ID
- EurobactII
- Acronym
- EurobactII
- Status last verified
- Sep 2021
- First submitted
- 1 May 2019
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 23011531Gajdos 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.
PubMed 40192823Buetti 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.
PubMed 36258239
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care: the Eurobact II Multinational Cohort Study
- ClinicalTrials.gov ID
- NCT03937245
- Acronym / sponsor ID
- EurobactII / EurobactII
- Conditions
- Bacteremia, Sepsis, Hospital Acquired Condition, Resistance Bacterial
- Keywords
- Hospital-acquired infection, Blood stream infection, Bacteremia, Intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,058 participants (actual)
- Lead sponsor
- Outcome ReaUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine, European Society of Clinical Microbiology and Infectious Diseases, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 3 Jun 2021 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HA-BSI | – | –Patients with HA-BSI treated in an ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a HA-BSI treated in an ICU
Key inclusion criteria (5 listed)
- Age > 18 Years.
- Hospital Acquired Bloodstream Infection (HA-BSI).
- Treated in the ICU.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 28 days
Vital status
4 secondary outcomes
Progress of organ failures
Time frame: 7 days
Days free or organ supportive therapy
Time frame: 28 days
Clinical cure
Time frame: 7 days, 28 days
Microbiological cure
Time frame: 7 days, 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Background: PubMed 23011531Tabah 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.
- Derived from this study: PubMed 40192823Gajdos 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.
- Derived from this study: PubMed 36258239Buetti 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.
- Eurobact II websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Bacteremia
RecruitingObservational study
Study of the Nasal Intracellular Reservoir of Staphylococcus Aureus in Patients With S. Aureus Bacteremia
Bacteria Infection Mechanism
Not yet recruitingPhase 4
Oral Switch in Bloodstream Infections in Immunocompromised Children
Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter
Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Tabah, MD principal investigator
ICU, Redcliffe Hospital, Faculty of Medicine, UQ, Brisbane, QLD, Australia.
Jean-Francois Timsit, MD,PhD study director
Medical and infectious diseases ICU, Bichat hospital, IAME U 1137,Paris,France
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteremia and Sepsis, run by Outcome Rea at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03937245, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.