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

NCT07202377 | Not Yet Recruiting

• 1 other identifier: APHP240793
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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 ICU.

Conditions

Gram-negative Bacteremia; Intensive Care Patients

Outcome Measures

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.

  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

  hour72 and hour96, and on day 7

• Proportion of patients with favorable microbiological evolution, defined by negative blood cultures collected between H72 and H96.

  hour72 and hour96

• Plasma concentration/MIC ratio observed at the first β-lactam level measurement between H24 and H48

  hour24 and hour48

• Proportion of patients alive at day 30 (D30) and at ICU discharge

  day 30

• Incidence of antibiotic-associated adverse events affecting renal, neurological, and hepatic function during the course of treatment

  day 30

Study Arms (2)

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

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.

Diagnostic Test: SPECIFIC REVEAL® Rapid AST system

Interventions

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 performed using the Reveal technique

antibiotic susceptibility testing on agar medium DIAGNOSTIC_TEST

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

Performance of an antibiotic susceptibility test on agar medium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Central Study Contacts

Françoise Jauréguy

CONTACT

01 48 95 56 69; francoise.jaureguy@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: October 1, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09