Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Conditions:

Gram-negative Bacteremia

Intensive Care Patients

Eligibility:

All Genders

18+ years

Phase:

NA

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 c...

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 t...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

October 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 1 2026

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT07202377

Start Date

October 1 2025

End Date

November 1 2026

Last Update

October 1 2025

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