Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-01 @ 4:10 AM
Study NCT ID:
NCT04156633
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2019-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Impact of Rapid Identification of Positive Blood Cultures vs. Internal Laboratory Standard
Sponsor:
University Hospital, Basel, Switzerland
Organization:
Study Overview
Official Title:
Clinical Impact of Rapid Identification of Positive Blood Cultures vs. Internal Laboratory Standard
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: