NCT04156633

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 800 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Bloodstream Infections

Interventions

Type	Name	Description
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)
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)
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)

Timeline

• Start date: 2019-10-17
• Primary completion: 2022-03-01
• Completion: 2022-07-31
• First posted: 2019-11-07
• Last updated: 2024-05-09

Locations

1 site across 1 country: Switzerland