NCT03000049

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

December 15, 2016

Last Update Submit

December 21, 2016

Conditions

Sepsis Septic Shock

Keywords

sepsisseptic shockblood culturesanti-infective therapy

Outcome Measures

Primary Outcomes (1)

  • Time to a significant change of antimicrobial therapy from the time of the diagnosis of sepsis or septic shock

    Nov. 2016 - Nov. 2017

Interventions

bedside blood cultureOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with sepsis or septic shock with planned blood culture drawing

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany

Greifswald, 17475, Germany

RECRUITING

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Central Study Contacts

Matthias Gründling, MD

CONTACT

gruendli@uni-greifswald.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sven-Olaf Kuhn MD

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 21, 2016

Study Start

November 1, 2016

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

December 22, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)