Clinical trial NCT03937245: Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care
Official title: Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care: the Eurobact II Multinational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Sepsis
Hospital Acquired Condition
Resistance Bacterial
Keywords: Hospital-acquired infection
Blood stream infection
Bacteremia
Intensive care
Lead sponsor: Outcome Rea
Sponsor class: OTHER
Collaborators: name: European Society of Intensive Care Medicine
name: European Society of Clinical Microbiology and Infectious Diseases
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2019-05-03
Enrollment: 3058
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a HA-BSI treated in an ICU

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality
timeFrame: 28 days
Secondary outcomes:
measure: Progress of organ failures
timeFrame: 7 days
measure: Days free or organ supportive therapy
timeFrame: 28 days
measure: Clinical cure
timeFrame: 7 days, 28 days
measure: Microbiological cure
timeFrame: 7 days, 28 days
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Redcliffe Hospital
state: Queensland
city: Paris
country: France
facility: Reanimation Medicale et Infectieuse-Hopital Bichat
Study officials:
affiliation: ICU, Redcliffe Hospital, Faculty of Medicine, UQ, Brisbane, QLD, Australia.
name: Alexis Tabah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical and infectious diseases ICU, Bichat hospital, IAME U 1137,Paris,France
name: Jean-Francois Timsit, MD,PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.