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

Completed

• Conditions: Bloodstream Infections

• Registration Number: NCT04156633
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-17
• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-07
• Primary Completion: 2022-03-01
• Study Completion: 2022-07-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Division of Clinical Bacteriology & Mycology, University Hospital Basel; 🇨🇭 Basel, Switzerland