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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

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

Clinicaltrials.gov identifier NCT03943719

Recruitment Status Completed

First Posted May 9, 2019

Last update posted May 9, 2019

Study Description

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.

  • Condition or Disease:Septicemia
  • Intervention/Treatment: Diagnostic Test: FilmArray blood culture identification panel
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational [Patient Registry]
  • Actual Enrollment: 139 participants
  • Observational Model: Case-Control
  • Time Perspective: Prospective
  • Official Title: The Impact of a Rapid Molecular Identification Test on Positive Blood Cultures From Critically Ill With Bacteremia: a Pre-post Intervention Study
  • Actual Study Start Date: March 2017
  • Actual Primary Completion Date: December 2017
  • Actual Study Completion Date: August 2018
Outcome Measures
  • Primary Outcome Measures: 1. 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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • Sampling Method: Non-Probability Sample
  • Study Population: adult intensive care unit patients with positive blood cultures
Criteria

Inclusion Criteria:

- adult intensive care unit patients with positive blood cultures

Exclusion Criteria:

- palliative care patients

Contacts and Locations
Contacts
Locations

Belgium
Cliniques universitaires St-Luc
Brussels

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

BioMérieux

Investigators

Principal Investigator: Alexia VERROKEN Cliniques universitaires St-Luc

More Information
  • Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  • ClinicalTrials.gov Identifier: NCT03943719 History of Changes
  • Other Study ID Numbers: SEPSIS2016, 2016/19SEP/401
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: May 9, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain: FilmArray
    bacteremia
    septicemia
    clinical impact
    molecular testing
    identification
    positive blood culture
    optimal antimicrobial treatment
  • Additional relevant MeSH terms: Sepsis Toxemia