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

March 10, 2020 updated by: SCARE (Study group for carbapenem resistance)
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

810

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a HA-BSI treated in an ICU

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HA-BSI
Patients with HA-BSI treated in an ICU
Other: Treatment
Antimicrobial and other treatment modalities such as source control, vasoactive medications, dialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality Rate
Time Frame: 28-day mortality
Rate of all cause mortality
28-day mortality

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress of organ failures
Time Frame: 7-day
Assessed by the components of the Sequential Organ Failure Assessment (SOFA) score, minimum (0 point)- Maximum (24 points)
7-day
Days free or organ supportive therapy
Time Frame: 28-day
Days free of renal replacement therapy, mechanical ventilation, vasopressors, intensive care unit
28-day
Rate of Clinical cure
Time Frame: 7-day and 28-day
As evaluated by the treating clinician. There will be no specific tool for evaluation of clinical cure. It will be only determined by the clinical assessment of admitting physicians.
7-day and 28-day
Rate of Microbiological cure
Time Frame: 7-day and 28-day
Presence of persisting or relapsing blood stream infection
7-day and 28-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCARE (Study group for carbapenem resistance)

Collaborators

European Society of Intensive Care Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2020

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

March 8, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (ACTUAL)

March 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA-19126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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