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.
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.
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 group | Role | What they receive |
|---|---|---|
| ASTAR | Experimental | Use 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.
Time tot first effective antibiotic therapy
Time tot first effective antibiotic therapy
Measured: 24 hours
Secondary outcomes (4)
Time to optimal antibiotic therapy
Time to optimal antibiotic therapy
Measured: 72 hours
Number of different antibiotic classes used in treatment
Number of different antibiotic classes used in treatment
Measured: 14 days
Time to stop antibiotic therapy
Time to stop antibiotic therapy
Measured: 14 days
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.
- First posted23 Jan 2024
- Study start10 Jan 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerina Boelens, Principal investigator, University Hospital, Ghent
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Antimicrobial Susceptibility Testing with MIC Directly from Positive Blood Cultures with ASTar
- ClinicalTrials.gov ID
- NCT06218277
- Acronym / sponsor ID
- RASTA / ONZ-2022-0379
- Conditions
- Bacteremia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective in one group of patients
| Arm | Type | Receives |
|---|---|---|
| ASTAR | Experimental | Diagnostic Test: ASTARUse of the early AST results for guidance of the antimicrobial therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with blood culture positive with gram negative bacilli
- -
Key exclusion criteria (3 listed)
- Mixed blood culture positivity on Gram stain
- Positive blood culture with gram negative bacilli in the previous 7 days
- Life expectancy of < 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASTARRapid AST with ASTAR | Diagnostic test | ASTAR |
Primary outcome
Time tot first effective antibiotic therapy
Time frame: 24 hours
Time tot first effective antibiotic therapy
4 secondary outcomes
Time to optimal antibiotic therapy
Time frame: 72 hours
Number of different antibiotic classes used in treatment
Time frame: 14 days
Time to stop antibiotic therapy
Time frame: 14 days
Time of empiric treatment
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 39862301Messiaen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerina Boelens principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
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.