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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SPECIFIC REVEAL® Rapid AST system

    Diagnostic 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 medium

    Diagnostic test

    Performance of an antibiotic susceptibility test on agar medium, with results expected between H18 and H24

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Performance of an antibiotic susceptibility test on agar mediumActive comparator 1 intervention
Group B: Antibiotic susceptibility testing performed using the Reveal techniqueExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 hours following the report of a positive blood culture for Gram-negative bacilli

Secondary outcomes

1

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

Time frame
hour72 and hour96, and on day 7
2

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

Time frame
hour72 and hour96
3

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).

Time frame
hour24 and hour48
4

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

Time frame
day 30

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: