Clinical Impact of Rapid Identification of Positive Blood Cultures vs. Internal Laboratory Standard

March 1, 2022 updated by: University Hospital, Basel, Switzerland
In this before-after study, different new methods for bacterial species identification from positive blood cultures will be compared towards historic controls. All samples are analyzed within the routine workflow for bacterial species identification and antibiotic resistance profiling. Patients with positive blood cultures from 2016 to 2018 receiving a conventional identification methods (controls) will be compared to patients from 2018 and 2019 with a new identification method (cases). The conventional identification method consisted in general of an over-night subculture and subsequent identification of the bacterial pathogen using either biochemical profiling or Matrix-assisted Laser-Desorption/Ionization Time-of-Flight (MALDI-TOF MS). The new identification of positive blood cultures methods include (i) either the newly introduced Biofire FilmArray© Blood Culture Identification (BCID) panel or (ii) in a subset of patients whole genome sequencing (WGS) approaches.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

686

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

  • Switzerland
      • Basel, Switzerland, 4031
        • Division of Clinical Bacteriology & Mycology, University Hospital Basel

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients with positive blood cultures hospitalized at the university hospital Basel between August 2016 and October 2019 are included.

Description

Inclusion Criteria:

  • patients with positive blood cultures hospitalized between August 2016 and October 2019
  • documented refusal of the general consent

Exclusion Criteria:

  • outpatients
  • patients hospitalized in other hospitals
  • patients with known bacteremia diagnosed in another hospital

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
conventional identification methods (controls)
Patients with positive blood cultures from 2016 to 2018 receiving a conventional identification methods (controls). The conventional identification method consisted in general of an over-night subculture and subsequent identification of the bacterial pathogen using either biochemical profiling or MALDI-TOF MS.
Diagnostic test: conventional identification method: biochemical profiling or MALDI-TOF MS
Identification of bacteria in positive blood cultures with MALDI-TOF MS from a subculture usually one day after the signal for a positive blood culture appears (from 2016 to 2018)
new identification method (cases)Biofire FilmArray© BCID panel
Patients with positive blood cultures from 2018 and 2019 receiving a new identification method (cases). The new identification method is the Biofire FilmArray© Blood Culture Identification (BCID) panel, a polymerase chain reaction-based method, performed directly from the positive blood culture without the need of subculture to reach single bacterial colonies. The assays allow to identify a panel of 20 most commonly Gram-positive and -negative bacteria and yeast causing blood stream infections. It also allows to determine three resistance genes (mecA, vanA/B and KPC).
Diagnostic test: new identification method: Biofire FilmArray© BCID panel
The Biofire FilmArray© BCID Panel is performed directly from the positive blood culture without the need of subculture to reach single bacterial colonies (from 2018 and 2019)
new identification method (cases) WGS approaches
Patients with positive blood cultures from 2018 and 2019 receiving a new identification method (cases). The new identification of positive blood cultures methods in a subset of patients is a whole genome sequencing approach. This so called shotgun metagenomic approach allows to sequence the whole genome (WGS) of pathogens and thereby potentially detect every potential pathogen and also resistance and virulence gene.
Diagnostic test: new identification method: metagenomic WGS
shotgun metagenomic approach allows to sequence the whole genome (WGS) of pathogens and thereby potentially detect every potential pathogen and also resistance and virulence gene (from 2018 and 2019)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to optimal antibiotic treatment in hours from positive blood cultures (hours)
Time Frame: 24 hours from collection of blood cultures
Time from blood draw for blood culture testing to start of optimal antibiotic treatment (hours)
24 hours from collection of blood cultures

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to effective antibiotic treatment in hours from positive blood cultures (hours)
Time Frame: 24 hours from collection of blood cultures
Time from blood draw for blood culture testing to start of effective antibiotic treatment (hours)
24 hours from collection of blood cultures
all-cause in hospital mortality (number)
Time Frame: from admission to hospital until release from hospital (approximately 30 days)
all-cause in hospital mortality (number)
from admission to hospital until release from hospital (approximately 30 days)
duration on ICU in days
Time Frame: from admission to ICU until release from ICU (approximately 20 days)
duration on ICU in days
from admission to ICU until release from ICU (approximately 20 days)
time to Gram staining and resistance profile from positive blood cultures (hours)
Time Frame: 24 hours from collection of blood cultures
time to Gram staining and resistance profile from positive blood cultures (hours)
24 hours from collection of blood cultures

Collaborators and Investigators

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

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Adrian Egli, PD Dr. med, Division of Clinical Bacteriology & Mycology; University Hospital Basel

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)

October 17, 2019

Primary Completion (Actual)

March 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

November 5, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-01860; qu19Egli2

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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