Clinical trial NCT04156633: Clinical Impact of Rapid Identification of Positive Blood Cultures vs. Internal Laboratory Standard
Official title: Clinical Impact of Rapid Identification of Positive Blood Cultures vs. Internal Laboratory Standard
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bloodstream Infections
Keywords: MALDI-TOF MS
Biofire FilmArray© Blood Culture Identification (BCID) panel
shotgun metagenomic approach
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with positive blood cultures hospitalized at the university hospital Basel between August 2016 and October 2019 are included.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to optimal antibiotic treatment in hours from positive blood cultures (hours)
timeFrame: 24 hours from collection of blood cultures
Secondary outcomes:
measure: Time to effective antibiotic treatment in hours from positive blood cultures (hours)
timeFrame: 24 hours from collection of blood cultures
measure: all-cause in hospital mortality (number)
timeFrame: from admission to hospital until release from hospital (approximately 30 days)
measure: duration on ICU in days
timeFrame: from admission to ICU until release from ICU (approximately 20 days)
measure: time to Gram staining and resistance profile from positive blood cultures (hours)
timeFrame: 24 hours from collection of blood cultures
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Division of Clinical Bacteriology & Mycology, University Hospital Basel
Study officials:
affiliation: Division of Clinical Bacteriology & Mycology; University Hospital Basel
name: Adrian Egli, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 cultures leads to faster optimal antimicrobial therapy - a before-after study. BMC Infect Dis. 2023 Oct 26;23(1):730. doi: 10.1186/s12879-023-08732-9.