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

• Sponsor: Outcome Rea (Other)
• Overall Status: Completed
• CT.gov ID: NCT03937245
• Collaborator: European Society of Intensive Care Medicine (Other), European Society of Clinical Microbiology and Infectious Diseases (Other), Institut National de la Santé Et de la Recherche Médicale, France (Other)
• Enrollment: 3,058
• Locations: 2
• Actual Duration (Months): 21.1
• Patients Per Site: 1529
• Patients Per Site Per Month: 72.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bacteremia; Sepsis; Hospital Acquired Condition; Resistance Bacterial

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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 3058 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care: the Eurobact II Multinational Cohort Study
• Actual Study Start Date: Aug 30, 2019
• Actual Primary Completion Date: Jun 2, 2021
• Actual Study Completion Date: Jun 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
HA-BSI Patients with HA-BSI treated in an ICU

Outcome Measures

Primary Outcome Measures

1. Mortality [28 days]

   Vital status

Secondary Outcome Measures

1. Progress of organ failures [7 days]

   Assessed by the components of the SOFA score

2. Days free or organ supportive therapy [28 days]

   Days free of renal replacement therapy, mechanical ventilation, vasopressors, intensive care unit

3. Clinical cure [7 days, 28 days]

   As evaluated by the treating clinician

4. Microbiological cure [7 days, 28 days]

   Presence of persisting or relapsing blood stream infection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Redcliffe Hospital	Brisbane	Queensland	Australia	4020
2	Reanimation Medicale et Infectieuse-Hopital Bichat	Paris		France	75018

Sponsors and Collaborators

• Outcome Rea
• 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

Investigators

• Principal Investigator: Alexis Tabah, MD, ICU, Redcliffe Hospital, Faculty of Medicine, UQ, Brisbane, QLD, Australia.
• Study Director: Jean-Francois Timsit, MD,PhD, Medical and infectious diseases ICU, Bichat hospital, IAME U 1137,Paris,France

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 19, 2019

More Information

Additional Information:

• Eurobact II website

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.

• Responsible Party: Outcome Rea
• ClinicalTrials.gov Identifier: NCT03937245
• Other Study ID Numbers: EurobactII
• First Posted: May 3, 2019
• Last Update Posted: Sep 9, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Outcome Rea: Hospital-acquired infection; Blood stream infection; Bacteremia; Intensive care
• Additional relevant MeSH terms: Infections; Bacteremia; Sepsis; Iatrogenic Disease

Study Results

No Results Posted as of Sep 9, 2021