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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04156633
Enrollment
800
Registered
2019-11-07
Start date
2019-10-17
Completion date
2022-07-31
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bloodstream Infections

Keywords

MALDI-TOF MS, Biofire FilmArray© Blood Culture Identification (BCID) panel, shotgun metagenomic approach

Brief summary

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.

Interventions

DIAGNOSTIC_TESTconventional 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)

DIAGNOSTIC_TESTnew 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)

DIAGNOSTIC_TESTnew 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)

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to optimal antibiotic treatment in hours from positive blood cultures (hours)24 hours from collection of blood culturesTime from blood draw for blood culture testing to start of optimal antibiotic treatment (hours)

Secondary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026