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

Bloodstream Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04156633
• Other study ID #: 2019-01860; qu19Egli2
• Status: Completed
• Start date: October 17, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: July 31, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bloodstream Infections
• Sepsis

Intervention

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)
• 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)
• 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)

Locations

Country	Name	City	State
Switzerland	Division of Clinical Bacteriology & Mycology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Agnetti J, Buchler AC, Osthoff M, Helfenstein F, Weisser M, Siegemund M, Bassetti S, Bingisser R, Schaefer DJ, Clauss M, Hinic V, Tschudin-Sutter S, Battig V, Khanna N, Egli A. Identification of microorganisms by a rapid PCR panel from positive blood cult — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to optimal antibiotic treatment in hours from positive blood cultures (hours)	Time from blood draw for blood culture testing to start of optimal antibiotic treatment (hours)	24 hours from collection of blood cultures
Secondary	Time to effective antibiotic treatment in hours from positive blood cultures (hours)	Time from blood draw for blood culture testing to start of effective antibiotic treatment (hours)	24 hours from collection of blood cultures
Secondary	all-cause in hospital mortality (number)	all-cause in hospital mortality (number)	from admission to hospital until release from hospital (approximately 30 days)
Secondary	duration on ICU in days	duration on ICU in days	from admission to ICU until release from ICU (approximately 20 days)
Secondary	time to Gram staining and resistance profile from positive blood cultures (hours)	time to Gram staining and resistance profile from positive blood cultures (hours)	24 hours from collection of blood cultures