Clinical Impact of the FilmArray Blood Culture Identification Panel Performed on Positive Blood Cultures From Intensive Care Patients With Septicemia (SEPSIS2016)

May 8, 2019 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

The Impact of a Rapid Molecular Identification Test on Positive Blood Cultures From Critically Ill With Bacteremia: a Pre-post Intervention Study

Molecular testing is a largely validated approach allowing rapid identification of positive blood cultures. However, due to its high cost and its limited information on susceptibility, it is considered as an add-on technique reserved for specific patient populations. In our study, we specifically evaluated molecular testing in a critical care setting and measured its impact on the therapeutic management of critically ill with positive blood cultures. Through the analysis of 110 positive blood culture episodes included in both pre- and post intervention period, we measured a drastic 14h-reduction of the time to administration of the optimal antimicrobial treatment with the use of the molecular approach.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

139

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

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires St-Luc

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult intensive care unit patients with positive blood cultures

Description

Inclusion Criteria:

  • adult intensive care unit patients with positive blood cultures

Exclusion Criteria:

  • palliative care patients

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Turn Around Time to optimal treatment of septicemia
Time Frame: From positivity detection of positive blood culture to administration of optimal treatment (up to 48 hours)
Time in minutes
From positivity detection of positive blood culture to administration of optimal treatment (up to 48 hours)

Collaborators and Investigators

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

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborators

BioMérieux

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 (ACTUAL)

March 1, 2017

Primary Completion (ACTUAL)

December 31, 2017

Study Completion (ACTUAL)

August 31, 2018

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 8, 2019

First Posted (ACTUAL)

May 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2019

Last Update Submitted That Met QC Criteria

May 8, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEPSIS2016
  • 2016/19SEP/401 (OTHER: CEHF)

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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