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

NCT ID: NCT04156633

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-17

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bloodstream Infections

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

conventional identification method: biochemical profiling or MALDI-TOF MS

Intervention Type DIAGNOSTIC_TEST

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).

new identification method: Biofire FilmArray© BCID panel

Intervention Type DIAGNOSTIC_TEST

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.

new identification method: metagenomic WGS

Intervention Type DIAGNOSTIC_TEST

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)

Interventions

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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)

Intervention Type 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)

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrian Egli, PD Dr. med

Role: PRINCIPAL_INVESTIGATOR

Division of Clinical Bacteriology & Mycology; University Hospital Basel

Locations

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Division of Clinical Bacteriology & Mycology, University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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Agnetti J, Buchler AC, Osthoff M, Helfenstein F, Weisser M, Siegemund M, Bassetti S, Bingisser R, Schaefer DJ, Clauss M, Hinic V, Tschudin-Sutter S, Battig V, Khanna N, Egli A. Identification of microorganisms by a rapid PCR panel from positive blood cultures leads to faster optimal antimicrobial therapy - a before-after study. BMC Infect Dis. 2023 Oct 26;23(1):730. doi: 10.1186/s12879-023-08732-9.

Reference Type RESULT
PMID: 37884860 (View on PubMed)

Other Identifiers

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2019-01860; qu19Egli2

Identifier Type: -

Identifier Source: org_study_id

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