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

University Hospital Basel

Status: Completed

Conditions: Bloodstream Infections

Treatments: Diagnostic Test: new identification method: Biofire FilmArray© BCID panel; Diagnostic Test: new identification method: metagenomic WGS; Diagnostic Test: conventional identification method: biochemical profiling or MALDI-TOF MS

Study type: Observational

Funder types: Other

Identifiers

NCT04156633

2019-01860 qu19Egli2;

Details and patient eligibility

About

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.

Enrollment: 800 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

800 participants in 3 patient groups

conventional identification methods (controls)

Description:

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.

Treatment:

Diagnostic Test: conventional identification method: biochemical profiling or MALDI-TOF MS

new identification method (cases)Biofire FilmArray© BCID panel

Description:

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).

Treatment:

Diagnostic Test: new identification method: Biofire FilmArray© BCID panel

new identification method (cases) WGS approaches

Description:

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.

Treatment:

Diagnostic Test: new identification method: metagenomic WGS