Bedside vs. Standard Microbiological Blood Culture Diagno... | NCT03000049

Studies
Bedside vs. Standard Microbiological Blood Culture Diagnostics - BEMIDIA Study

NCT03000049

Sponsor

University Medicine Greifswald

Status

Unknown status

Last Update Posted

Dec 22, 2016Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Sepsis Septic Shock

Interventions

bedside blood culture

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Jul 2017Estimated

Completion Date

Sep 2017Estimated

First Submitted Date

Dec 15, 2016

First Submission Date that Met QC Criteria

Dec 18, 2016

First Posted Date

Dec 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2016

Last Update Posted Date

Dec 22, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sven-Olaf Kuhn, Sven-Olaf Kuhn MD, University Medicine GreifswaldPrincipal Investigator

Lead Sponsor

University Medicine GreifswaldOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Name	Type	Description	Arm Group Labels	Other Names
bedside blood culture	Other

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with sepsis or septic shock with planned blood culture drawing

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matthias Gründling, MD	Contact			gruendli@uni-greifswald.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany	Recruiting	Greifswald		17475	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D012772	Shock, Septic

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided