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BacteremiaRASTANCT06218277

Rapid Antimicrobial Susceptibility Testing with MIC Directly from Positive Blood Cultures with ASTar

A study testing ASTAR in people with Bacteremia, run by University Hospital, Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Bacteremia
What is being tested?
ASTAR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteBelgium
Study dates
10 Jan 2024to 31 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with blood culture positive with gram negative bacilli
  • -

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Ghent University Hospital

    Ghent, 9000

Other trials in Belgium

About this study

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.

Read the 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)
Conditions
Bacteremia
Being tested
ASTAR
Medical subject headings
Bacteremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASTARDiagnostic test

    Rapid AST with ASTAR

Study groups in NCT06218277
Study groupRoleWhat they receive
ASTARExperimentalUse of the early AST results for guidance of the antimicrobial therapy
Receives: Diagnostic Test: ASTAR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time tot first effective antibiotic therapy

    Time tot first effective antibiotic therapy

    Measured: 24 hours

Secondary outcomes (4)
  1. Time to optimal antibiotic therapy

    Time to optimal antibiotic therapy

    Measured: 72 hours

  2. Number of different antibiotic classes used in treatment

    Number of different antibiotic classes used in treatment

    Measured: 14 days

  3. Time to stop antibiotic therapy

    Time to stop antibiotic therapy

    Measured: 14 days

  4. Time of empiric treatment

    Time of empiric treatment

    Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study start10 Jan 2024
  3. Primary completion31 Aug 2024
  4. Study completion31 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective in one group of patients
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06218277
Sponsor's protocol ID
ONZ-2022-0379
Acronym
RASTA
Status last verified
Sep 2024
First submitted
18 Dec 2023
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Messiaen AS, Vandendriessche S, De Muynck E, Strubbe G, De Bus L, Schelstraete P, Decommer K, De Smet S, Soetens A, Naesens L, Timmermans K, De Waele JJ, Veld DHI', Boelens J. Impact of reporting rapid susceptibility results in Gram negative bloodstream infections: a real world prospective study. Eur J Clin Microbiol Infect Dis. 2025 Apr;44(4):847-853. doi: 10.1007/s10096-025-05046-3. Epub 2025 Jan 25.

    PubMed 39862301

Questions about this trial

What is this clinical trial studying?

A study testing ASTAR in people with Bacteremia, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time tot first effective antibiotic therapy (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06218277, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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