Bedside vs. Standard Microbiological Blood Culture Diagnostics - BEMIDIA Study

Sepsis Septic Shock Clinical Trial

— BEMIDIA  

Official title:

Bedside vs. Standard Microbiological Blood Culture Diagnostics - BEMIDIA Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03000049
• Other study ID #: SD_BK_1_ANI
• Status: Recruiting
• Phase: N/A
• First received: December 15, 2016
• Last updated: December 21, 2016
• Start date: November 2016
• Est. completion date: September 2017

Study information

• Verified date: December 2016
• Source: University Medicine Greifswald
• Contact: Matthias Gründling, MD
• Email: gruendli[@]uni-greifswald.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Sepsis Septic Shock
• Shock, Septic

Intervention

Other:
• bedside blood culture

Locations

Country	Name	City	State
Germany	Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to a significant change of antimicrobial therapy from the time of the diagnosis of sepsis or septic shock		Nov. 2016 - Nov. 2017	No