Bedside vs. Standard Microbiological Blood Culture Diagnostics - BEMIDIA Study (BEMIDIA)

December 21, 2016 updated by: Sven-Olaf Kuhn, University Medicine Greifswald

With a completely bedside blood culture diagnostics system (BACTEC blood culture system in combination with the Accelerate ID/AST System) it is possible to optimize the initial antimicrobial therapy in patients with sepsis and septic shock.

Prospective observational, open-label mono-center study to compare a completely bedside blood culture diagnostics system (BACTEC blood culture system in combination with the Accelerate ID/AST System and Curetis Univero System) with standard blood culture diagnostics in patients with sepsis or septic shock.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

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

Study Locations

  • Germany
      • Greifswald, Germany, 17475
        • Recruiting
        • Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany
        • Contact:
        • Contact:
          • Matthias Gründling, MD
        • Principal Investigator:
          • Matthias Gründling, MD

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 sepsis or septic shock with planned blood culture drawing

Description

Inclusion Criteria:

  • Patients with a new diagnosed sepsis or septic shock: emergency department, operating theatre, intensive care unit and planed blood culture diagnostics.
  • informed written consent

Exclusion Criteria:

  • Pediatric patients (< 18 Years)
  • DNR-order

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to a significant change of antimicrobial therapy from the time of the diagnosis of sepsis or septic shock
Time Frame: Nov. 2016 - Nov. 2017
Nov. 2016 - Nov. 2017

Collaborators and Investigators

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

Sponsor

University Medicine Greifswald

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

November 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

December 18, 2016

First Posted (Estimate)

December 21, 2016

Study Record Updates

Last Update Posted (Estimate)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 21, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SD_BK_1_ANI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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