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Clinical Trials/NCT04304456
NCT04304456
Unknown
Not Applicable

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

SCARE (Study group for carbapenem resistance)0 sites810 target enrollmentJune 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bacteremia
Sponsor
SCARE (Study group for carbapenem resistance)
Enrollment
810
Primary Endpoint
Mortality Rate
Last Updated
6 years ago

Overview

Brief Summary

In this observational study, it is aimed to investigate the mortality and morbidity rates of hospital-acquired blood stream infections that are treated in intensive care units (ICU). The effects of properties of the micro-organism such as type and antimicrobial resistance on the infection and its outcomes will be mainly explored. In addition, the impact of antibiotic options and other treatment modalities on survival of patients will be investigated. Twenty-seven different ICUs from Turkey will be included in this study.

Detailed Description

Blood stream infection (BSI) is defined as the identification of a culprit pathogen in the blood culture sample of a participant. As such, and once contaminants are excluded, BSI is the only cause of sepsis where the presence of an infection and the pathogen are known with certainty. This makes BSI the perfect model of infection to study the effects of the micro-organism on the participant, and the effects of the antibiotics and other treatments on survival. There is an increasing trend in antimicrobial resistance rates among microorganisms that are associated with nosocomial infections treated in ICU. However, infectious diseases physicians from Turkey do not know contemporary epidemiological data of hospital-acquired BSI treated in ICU in Turkey. This study 'Epidemiology and Determinants of Outcomes of Hospital-Acquired Blood Stream Infections in the Intensive Care in Turkey' is a multi-center prospective observational cohort study that will include patients with hospital-acquired blood stream infections (HA-BSI) treated in ICUs in Turkey. This study will present unknown current epidemiology of HA-BSI in Turkey. Furthermore, It will provide very important data about 28-day mortality rates of HA-BSI treated in ICU. The primary outcomes of this study can be accounted as following: (i)determinants of outcomes of HA-BSI, (ii) the effects of the source of infection on outcomes, (iii) the effects of microorganism on these outcomes, (iv) the effects of antimicrobial therapy and of source control on investigated outcomes. In this study, participant specific and organizational factors will be explored and the determinants of management of HA-BSI in ICUs will be described. There will be no intervention in this study. The data of participants will be obtained from hospital database and recorded into electronic case report forms anonymously.

Registry
clinicaltrials.gov
Start Date
June 2020
End Date
April 2022
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
SCARE (Study group for carbapenem resistance)
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Mortality Rate

Time Frame: 28-day mortality

Rate of all cause mortality

Secondary Outcomes

  • Rate of Microbiological cure(7-day and 28-day)
  • Days free or organ supportive therapy(28-day)
  • Progress of organ failures(7-day)
  • Rate of Clinical cure(7-day and 28-day)

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