NCT03943719

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

10 months

First QC Date

May 8, 2019

Last Update Submit

May 8, 2019

Conditions

Septicemia

Keywords

FilmArraybacteremiasepticemiaclinical impactmolecular testingidentificationpositive blood cultureoptimal antimicrobial treatment

Outcome Measures

Primary Outcomes (1)

  • Turn Around Time to optimal treatment of septicemia

    Time in minutes

    From positivity detection of positive blood culture to administration of optimal treatment (up to 48 hours)

Interventions

FilmArray blood culture identification panelDIAGNOSTIC_TEST

FilmArray blood culture identification panel is performed 24 hours on 24hours and 7 days a week on positive blood cultures to accelerate pathogens detection

Eligibility Criteria

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

adult intensive care unit patients with positive blood cultures

You may qualify if:

  • adult intensive care unit patients with positive blood cultures

You may not qualify if:

  • palliative care patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires St-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

SepsisBacteremia

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Alexia VERROKEN

    Cliniques universitaires St-Luc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 9, 2019

Study Start

March 1, 2017

Primary Completion

December 31, 2017

Study Completion

August 31, 2018

Last Updated

May 9, 2019

Record last verified: 2019-05

Locations

BE(1)