Rapid Antimicrobial Susceptibility Testing With MIC Directly From Positive Blood Cultures With ASTar (RASTA)

The investigators want to investigate the clinical impact of early antimicrobial susceptibility results for gram negative bacilli isolated from blood cultures on antimicrobial choices and early switches of antimicrobial therapy.

Study Overview

• Status: Recruiting
• Conditions: Bacteremia
• Intervention / Treatment: Diagnostic test: ASTAR

Detailed Description

Sepsis and septic shock are defined as a (life-threatening) organ dysfunction caused by an (uncontrolled) host response to an infection. Sepsis remains a leading cause of morbidity and mortality worldwide. In addition, sepsis is also associated with prolonged hospitalization and additional healthcare costs.

Sepsis and septic shock can be caused by a bloodstream infection. If bloodstream infection is suspected, blood cultures are collected.

In recent years, various devices and methods have been developed to make an antibiogram possible after a few hours, instead of the next day. The Q-linea AStar system will be used for this purpose in the medical microbiology laboratory. In contrast to the classic method, blood from the blood culture is not grafted onto a growth medium, but this blood is placed in a specific cartridge on the device, after which automatic sample processing takes place, which after six hours leads to a definitive susceptibility result for a large number of gram-negative bacilli and causes of bloodstream infections. Moreover, the reported antibiogram is not based on disk diffusion but on 'broth' microdilution (ISO 2776-1) where the sensitivity to a specific antibiotic is determined on the basis of a dilution series. This method allows sensitivity to be reported not only qualitatively (sensitive or resistant), but also allows reporting of the minimum inhibitory concentration (MIC value). This is the lowest concentration of an antibiotic at which the growth of the bacteria is inhibited and this fact allows the dose administered to be optimized if necessary.

The aim of this study is therefore, if this new method can be implemented, to retrospectively determine whether making the antibiogram more quickly available in the epidemiological setting of Ghent University Hospital offers added value: does the early available information lead to necessary and beneficial antibiotherapy changes or does the traditional diagnosis with reporting one day later prove to be equivalent? If the new working method were to lead to a clinically significant improvement in the established policy, this could necessitate an organizational adjustment in the operation of the laboratory.

To gain insight into this, clinical data will be collected during the study period necessary to evaluate the extent to which the faster results have had an impact on the antibiotherapy. There is therefore no need for additional sample collection from the patient. All collected data result from the standard hemoculture taken due to fever and/or frissons and concern clinical data that is routinely collected to formulate antibiotic recommendations for patients with positive hemocultures.

The following data will be collected pseudonymised for samples processed according to the new best practice:

• sample number
• gender and year of birth, date of sample inclusion
• presumed source of infection, empirically administered antibiotic
• time-to-positivity of the blood culture bottle (TTP), type blood culture bottle
• result of gram stain & duration until reporting, any antibiotic change based on. gram stain
• causative germ and resistance profile (e.g. ESBL, Multi-Drug Resistant P.aeruginosa, ...)
• result of antibiogram & duration until reporting (both methods), formulated advice, any antibiotic change based on. initially formulated advice (effect on antibiotic decision making), if necessary, additional advice and their associated impact on antibiotic policy
• time-to-first effective antibiotherapy, time-to-effective antibiotherapy based on antibiogram, time-to-optimal antibiotherapy, time-to-stop antibiotherapy, number of antibiotic days, antibiotic exposure (different classes for example), duration of empirical treatment (with T0 collection time of the hemoculture)

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
    • Contact: Jerina Boelens; Phone Number: +3293321969; Email: jerina.boelens@uzgent.be
    • Contact: Diana Huis in't Veld; Phone Number: +3293322111; Email: diana.huisintveld@uzgent.be
    • Sub-Investigator: Stien Vandendriessche
    • Sub-Investigator: Anne-Sophie Messiaen
    • Sub-Investigator: Jan Dewaele
    • Sub-Investigator: Liesbet De Bus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients with blood culture positive with gram negative bacilli

-

Exclusion Criteria:

• Mixed blood culture positivity on Gram stain
• Positive blood culture with gram negative bacilli in the previous 7 days
• Life expectancy of < 48 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASTAR; Use of the early AST results for guidance of the antimicrobial therapy	Diagnostic test: ASTAR; Rapid AST with ASTAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time tot first effective antibiotic therapy	Time tot first effective antibiotic therapy	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to optimal antibiotic therapy	Time to optimal antibiotic therapy	72 hours
Number of different antibiotic classes used in treatment	Number of different antibiotic classes used in treatment	14 days
Time to stop antibiotic therapy	Time to stop antibiotic therapy	14 days
Time of empiric treatment	Time of empiric treatment	72 hours

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Jerina Boelens, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia
• Other Study ID Numbers: ONZ-2022-0379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No