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NCT Number: NCT04156633

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

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.

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Key information

Conditions

Bloodstream Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Clinical Bacteriology & Mycology, University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional identification method: biochemical profiling or MALDI-TOF MS

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: Biofire FilmArray© BCID panel

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: metagenomic WGS

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)

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. duration on ICU in days

    Time frame: from admission to ICU until release from ICU (approximately 20 days)

    duration on ICU in days

  4. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 7, 2019
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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