Gram-negative BacteremiaCMIBActRéaNCT07202377
Impact of Real-time MIC (Minimum Inhibitory Concentration) Reporting (<6 Hours) on β-lactam Prescription in Cases of Gram-negative Bacilli Bacteremia in ICU Patients in Real-life Settings
A study testing SPECIFIC REVEAL® Rapid AST system and antibiotic susceptibility testing on agar medium in people with Gram-negative Bacteremia and Intensive Care Patients, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Evaluate the impact of rapid, real-time (4 to 6 h) MIC reporting compared with the standard method (=diffusion antibiotic susceptibility testing) (18 to 24 h) on β-lactam prescribing in terms of the choice of molecule by the resuscitating clinician in the event of real-life Gram-negative Bacilli GNB bacteremia in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gram-negative Bacteremia, Intensive Care Patients
- What is being tested?
- SPECIFIC REVEAL® Rapid AST system and antibiotic susceptibility testing on agar medium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged over 18 years
- Patients with a positive blood culture for Gram-negative bacilli (Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii) with results reported on weekdays before 11:00 ante meridiem (AM)
- Patients clinically suspected of infection
- Treated with empirical antibiotic therapy including a β-lactam, among the standard list of antibiotics to be tested recommended by CASFM-EUCAST (European Committee on Antimicrobial Susceptibility Testing) for Enterobacterales/Pseudomonas and included in the Reveal Rapid AST System panel
- Hospitalized in intensive care unit (ICU) for at least the next 24 hours
- Written informed consent obtained from the patient or a relative for study participation (emergency consent)
- Affiliated with the French social security system
Who cannot join
- Patients receiving withdrawal or limitation of care
- Patients with an expected survival prognosis of less than 72 hours
- Patients with bloodstream infections caused by Gram-negative bacilli other than Acinetobacter baumannii, Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa
- Patients treated with antibiotic therapy not including a β-lactam
- Polymicrobial bloodstream infections
- Pregnant or breastfeeding women
- Patients under legal protection (guardianship or conservatorship)
- Participation in another interventional research study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Evaluate the impact of rapid, real-time (4 to 6 h) MIC reporting compared with the standard method (=diffusion antibiotic susceptibility testing) (18 to 24 h) on β-lactam prescribing in terms of the choice of molecule by the resuscitating clinician in the event of real-life Gram-negative Bacilli GNB bacteremia in the ICU.
Read the detailed description
In the microbiology laboratory, antibiotic susceptibility is traditionally determined using the disk diffusion method on agar medium, directly from a positive blood culture bottle, which requires 18 to 24 hours of incubation. Over the past decade, the turnaround time for antibiotic susceptibility testing has been shortened (down to 7 hours) thanks to rapid diagnostic tools. However, to date, there is no rapid (within 4 to 6 hours) and accurate method for determining the Minimum Inhibitory Concentration (MIC) that would allow for optimized antibiotic treatment beyond the basic susceptibility to a tested drug. This level of precision would be particularly useful in critically ill septic patients, especially in cases of bacteremia caused by Gram-negative bacilli (GNB).
Recent intensive care guidelines have suggested that for β-lactam antibiotics, the therapeutic target in these patients should be a plasma antibiotic concentration between 4 to 8 times the MIC of the administered antibiotic, depending on the bacterium and the drug. MIC thus represents a key determinant for optimizing antibiotic therapy by increasing the likelihood of achieving the pharmacodynamic efficacy targets of β-lactams.
The use of a new instrument, the SPECIFIC REVEAL® Rapid AST system (bioMérieux), which provides not only a full antibiogram but also MIC values for 23 different antibiotics as early as 4 hours after a positive GNB blood culture (Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii), could represent a potential benefit for ICU patients by enabling rapid optimization of antibiotic therapy. This technique was validated by comparison with two reference methods: a precise MIC determination method (broth microdilution, Sensititre, ThermoFisher) and an approximate method (Vitek2, bioMérieux). A 96% correlation was observed across the 23 antibiotics tested. Furthermore, a recent study conducted outside the ICU suggested a clinical impact, with earlier re-evaluation of antibiotic choices in 58% of cases.
- Conditions
- Gram-negative Bacteremia, Intensive Care Patients
- Being tested
- SPECIFIC REVEAL® Rapid AST system, antibiotic susceptibility testing on agar medium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECIFIC REVEAL® Rapid AST systemDiagnostic test
The SPECIFIC REVEAL™ system uses biosensors capable of detecting volatile substances released by microorganisms during their growth. The detection of these volatile compounds by ultra-high-performance biosensors enables very early detection of bacterial growth compared with standard technologies based on visual systems (e.g. diffusion antibiogram or MICs determined by microdilution in liquid media) or optical density measurement systems (e.g. Vitek2)
antibiotic susceptibility testing on agar mediumDiagnostic test
Performance of an antibiotic susceptibility test on agar medium, with results expected between H18 and H24
| Study group | Role | What they receive |
|---|---|---|
| Performance of an antibiotic susceptibility test on agar medium | Active comparator | Performance of an antibiotic susceptibility test on agar medium, with results expected between H18 and H24 Receives: Diagnostic Test: antibiotic susceptibility testing on agar medium |
| Antibiotic susceptibility testing performed using the Reveal technique | Experimental | Antibiotic susceptibility testing performed using the Reveal technique, with results available between the 4th and 6th hour (H4-H6) after blood culture positivity, allowing for rapid clinical categorization for the 23 antibiotics tested, along with their corresponding MICs. Receives: Diagnostic Test: SPECIFIC REVEAL® Rapid AST system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients for whom antibiotic therapy was modified in terms of molecule selection within the first 24 hours following the report of a positive blood culture for Gram-negative bacilli, based on medical prescriptions after inclusion
To evaluate whether the rapid and real-time reporting (4 to 6 hours) of MICs, compared to the standard method (i.e., disk diffusion antibiogram, 18 to 24 hours), has an impact on β-lactam prescription in terms of molecule selection by the ICU clinician in real-life cases of bloodstream infections due to Gram-negative bacilli.
Measured: 24 hours following the report of a positive blood culture for Gram-negative bacilli
Secondary outcomes (6)
Proportion of patients with favorable clinical and biological evolution based on the Sequential Organ Failure Assessment (SOFA) score between H72 and H96, and on day 7
To evaluate the impact of rapid MIC reporting compared to the standard method (i.e., disk diffusion, which provides only clinical categorization) on clinical and biological outcomes between H72 and H96, and on day 7
Measured: hour72 and hour96, and on day 7
Proportion of patients with favorable microbiological evolution, defined by negative blood cultures collected between H72 and H96.
To evaluate the impact of rapid MIC reporting compared to the standard method (i.e., disk diffusion, which provides only clinical categorization) on microbiological evolution between H72 and H96
Measured: hour72 and hour96
Plasma concentration/MIC ratio observed at the first β-lactam level measurement between H24 and H48
To evaluate the impact of rapid MIC reporting compared to the standard method (i.e., disk diffusion, which provides only clinical categorization) on the probability of achieving a residual β-lactam plasma concentration between 4 and 8 times the MIC at the first antibiotic measurement between 24 and 48 hours (H24-H48).
Measured: hour24 and hour48
Proportion of patients alive at day 30 (D30) and at ICU discharge
To evaluate the impact of rapid MIC reporting compared to the standard method (i.e., disk diffusion, which provides only clinical categorization) on mortality at day 30 (D30) and at ICU discharge
Measured: day 30
Incidence of antibiotic-associated adverse events affecting renal, neurological, and hepatic function during the course of treatment
To evaluate the impact of rapid MIC reporting compared to the standard method (i.e., disk diffusion, which provides only clinical categorization) on the incidence of antibiotic-related adverse effects (renal, neurological, hepatic tolerance) throughout the treatment.
Measured: day 30
Costs associated with rapid MIC testing, hospital stay, antibiotics, and microbiological tests as well as costs assessed at 30 days.
To evaluate the medico-economic impact of the rapid MIC reporting strategy through a cost-consequence analysis, which allows for a disaggregated presentation of the consequences of rapid MIC reporting for patients, prescribers, and the microbiology department; costs are estimated from the healthcare provider's perspective
Measured: day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study startOct 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-negative BacteremiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202377
- Sponsor's protocol ID
- APHP240793
- Acronym
- CMIBActRéa
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Real-time MIC (Minimum Inhibitory Concentration) Reporting (<6 Hours) on β-lactam Prescription in Cases of Gram-negative Bacilli Bacteremia in ICU Patients in Real-life Settings
- ClinicalTrials.gov ID
- NCT07202377
- Acronym / sponsor ID
- CMIBActRéa / APHP240793
- Conditions
- Gram-negative Bacteremia, Intensive Care Patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 1 Oct 2025 (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.
Evaluate the impact of rapid, real-time (4 to 6 h) MIC reporting compared with the standard method (=diffusion antibiotic susceptibility testing) (18 to 24 h) on β-lactam prescribing in terms of the choice of molecule by the resuscitating clinician in the event of real-life Gram-negative Bacilli GNB bacteremia in the ICU.
Detailed description
In the microbiology laboratory, antibiotic susceptibility is traditionally determined using the disk diffusion method on agar medium, directly from a positive blood culture bottle, which requires 18 to 24 hours of incubation. Over the past decade, the turnaround time for antibiotic susceptibility testing has been shortened (down to 7 hours) thanks to rapid diagnostic tools. However, to date, there is no rapid (within 4 to 6 hours) and accurate method for determining the Minimum Inhibitory Concentration (MIC) that would allow for optimized antibiotic treatment beyond the basic susceptibility to a tested drug. This level of precision would be particularly useful in critically ill septic patients, especially in cases of bacteremia caused by Gram-negative bacilli (GNB).
Recent intensive care guidelines have suggested that for β-lactam antibiotics, the therapeutic target in these patients should be a plasma antibiotic concentration between 4 to 8 times the MIC of the administered antibiotic, depending on the bacterium and the drug. MIC thus represents a key determinant for optimizing antibiotic therapy by increasing the likelihood of achieving the pharmacodynamic efficacy targets of β-lactams.
The use of a new instrument, the SPECIFIC REVEAL® Rapid AST system (bioMérieux), which provides not only a full antibiogram but also MIC values for 23 different antibiotics as early as 4 hours after a positive GNB blood culture (Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii), could represent a potential benefit for ICU patients by enabling rapid optimization of antibiotic therapy. This technique was validated by comparison with two reference methods: a precise MIC determination method (broth microdilution, Sensititre, ThermoFisher) and an approximate method (Vitek2, bioMérieux). A 96% correlation was observed across the 23 antibiotics tested. Furthermore, a recent study conducted outside the ICU suggested a clinical impact, with earlier re-evaluation of antibiotic choices in 58% of cases.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Performance of an antibiotic susceptibility test on agar medium | Active comparator | Diagnostic Test: antibiotic susceptibility testing on agar mediumPerformance of an antibiotic susceptibility test on agar medium, with results expected between H18 and H24 |
| Antibiotic susceptibility testing performed using the Reveal technique | Experimental | Diagnostic Test: SPECIFIC REVEAL® Rapid AST systemAntibiotic susceptibility testing performed using the Reveal technique, with results available between the 4th and 6th hour (H4-H6) after blood culture positivity, allowing for rapid clinical categorization for the 23 antibiotics tested, along with their corresponding MICs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients aged over 18 years
- Patients with a positive blood culture for Gram-negative bacilli (Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii) with results reported on weekdays before 11:00 ante meridiem (AM)
- Patients clinically suspected of infection
- Treated with empirical antibiotic therapy including a β-lactam, among the standard list of antibiotics to be tested recommended by CASFM-EUCAST (European Committee on Antimicrobial Susceptibility Testing) for Enterobacterales/Pseudomonas and included in the Reveal Rapid AST System panel
- Hospitalized in intensive care unit (ICU) for at least the next 24 hours
Key exclusion criteria (8 listed)
- Patients receiving withdrawal or limitation of care
- Patients with an expected survival prognosis of less than 72 hours
- Patients with bloodstream infections caused by Gram-negative bacilli other than Acinetobacter baumannii, Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa
- Patients treated with antibiotic therapy not including a β-lactam
- Polymicrobial bloodstream infections
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 |
|---|---|---|
| SPECIFIC REVEAL® Rapid AST systemThe SPECIFIC REVEAL™ system uses biosensors capable of detecting volatile substances released by microorganisms during their growth. The detection of these volatile compounds by ultra-high-performance biosensors enables very early detection of bacterial growth compared with standard technologies based on visual systems (e.g. diffusion antibiogram or MICs determined by microdilution in liquid media) or optical density measurement systems (e.g. Vitek2) | Diagnostic test | Antibiotic susceptibility testing performed using the Reveal technique |
| antibiotic susceptibility testing on agar mediumPerformance of an antibiotic susceptibility test on agar medium, with results expected between H18 and H24 | Diagnostic test | Performance of an antibiotic susceptibility test on agar medium |
Primary outcome
Proportion of patients for whom antibiotic therapy was modified in terms of molecule selection within the first 24 hours following the report of a positive blood culture for Gram-negative bacilli, based on medical prescriptions after inclusion
Time frame: 24 hours following the report of a positive blood culture for Gram-negative bacilli
To evaluate whether the rapid and real-time reporting (4 to 6 hours) of MICs, compared to the standard method (i.e., disk diffusion antibiogram, 18 to 24 hours), has an impact on β-lactam prescription in terms of molecule selection by the ICU clinician in real-life cases of bloodstream infections due to Gram-negative bacilli.
6 secondary outcomes
Proportion of patients with favorable clinical and biological evolution based on the Sequential Organ Failure Assessment (SOFA) score between H72 and H96, and on day 7
Time frame: hour72 and hour96, and on day 7
Proportion of patients with favorable microbiological evolution, defined by negative blood cultures collected between H72 and H96.
Time frame: hour72 and hour96
Plasma concentration/MIC ratio observed at the first β-lactam level measurement between H24 and H48
Time frame: hour24 and hour48
Proportion of patients alive at day 30 (D30) and at ICU discharge
Time frame: day 30
Incidence of antibiotic-associated adverse events affecting renal, neurological, and hepatic function during the course of treatment
Time frame: day 30
Costs associated with rapid MIC testing, hospital stay, antibiotics, and microbiological tests as well as costs assessed at 30 days.
Time frame: day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing SPECIFIC REVEAL® Rapid AST system and antibiotic susceptibility testing on agar medium in people with Gram-negative Bacteremia and Intensive Care Patients, run by Assistance Publique - Hôpitaux de Paris.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Françoise Jauréguy (01 48 95 56 69, francoise.jaureguy@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients for whom antibiotic therapy was modified in terms of molecule selection within the first 24 hours following the report of a positive blood culture for Gram-negative bacilli, based on medical prescriptions after inclusion (time frame: 24 hours following the report of a positive blood culture for Gram-negative bacilli). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025.