Impact of Performing a Rapid Antibiotic Susceptibility Test on Antibiotic Therapy Adaptation in Adult Patients with Enterobacterales Bacteremia (MHR-Blood)

Impact of Performing a Rapid Antibiotic Susceptibility Test (MHR-SIR) on Antibiotic Therapy Adaptation in Adult Patients with Enterobacterales Bacteremia, Controlled, Randomized Cluster and Cross-over Study

Bacteremia is defined as the presence of bacteria in the blood. They can potentially lead to life-threatening septic shock.

Effective probabilistic antibiotic therapy must therefore be initiated immediately after blood cultures have been taken.

To diagnose bacteremia, blood culture bottles must first be incubated, which allows bacterial growth and early detection. Then, as soon as the sample is positive, an antibiogram of the incriminated bacterium is carried out by inoculation on MH (Mueller Hinton) medium. This diffusion antibiogram is the reference method and is obtained 24 hours after the vial is positive, i.e. around 48 hours after blood cultures are taken.

American recommendations agree that it is crucial to use rapid diagnostic tests to obtain the antibiogram. Antibiotic susceptibility test data can be used to broaden the spectrum of antibiotics in the event of ineffective therapy. They can also be used to reduce the spectrum of broad-spectrum antibiotics. This is part of the proper use of antibiotics and the reduction of multi-resistant bacteria (MRB) or highly resistant bacteria (HRB). Finally, it is also possible to carry out an early oral relay, thus avoiding intravenous infusions and their complications, and potentially reducing hospitalization times.

The investigators have evaluated a rapid antibiogram by diffusion on MHR-SIR (Mueller-Hinton Rapid-SIR) medium from the blood culture bottle. The investigators were able to obtain antibiogram results 7 hours after blood culture positivity, with excellent correlation compared with the standard method after 24 hours incubation on MH (Mueller-Hinton). The antibiotics tested were the same as with the standard method.

Secondly, The investigators were able to evaluate prospectively the impact of diffusion antibiotic susceptibility testing on MHR-SIR medium on early modification of antibiotic therapy in bacteremia, on 167 patients Antibiotic susceptibility test data on MHR-SIR enabled us to adapt antibiotic therapy 8 hours after blood culture positivity for 74 patients (44%). Antibiotic therapy was ineffective for 30 patients (18%) and was therefore extended. It also enabled us to reduce the spectrum of antibiotic therapy, in particular through early oral relay, for 44 patients (26%).

The aim of this multicenter trial is to validate on a large scale this strategy for obtaining rapid antibiotic susceptibility test results, with significant consequences in terms of optimizing antibiotic therapy.

Study Overview

• Status: Recruiting
• Conditions: Bacteremia
• Intervention / Treatment: Diagnostic test: Antibiotic susceptibility testing

• Study Type: Interventional
• Enrollment (Estimated): 960
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helene BEAUSSIER; Phone Number: +33144127038; Email: crc@ghpsj.fr
• Study Contact Backup: Name: Juliette COURTIADE MAHLER; Phone Number: +33144127963; Email: jcourtiade@ghpsj.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • Hopital Paris Saint Joseph
    • Contact: Helene BEAUSSIER; Phone Number: 0144127038; Email: hbeaussier@ghpsj.fr
    • Contact: Juliette COURTIADE MAHLER; Phone Number: 0144127963; Email: jcourtiade@ghpsj.Fr
    • Contact: Jean-claude NGUYEN VAN, pharmaD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age >= 18
• Patient hospitalized in a clinical department of each participating center
• Patient managed in the context of bacteremia (microbiological criterion = positive blood culture)
• Patient with positive blood culture for Enterobacterales
• Patient affiliated to a health insurance scheme
• Patient/relative having given free, informed and express oral consent

Exclusion Criteria:

• Patients with non-enterobacterial bacteremia
• Patient under guardianship
• Patient deprived of liberty
• Patient under court protection
• Pregnant or breast-feeding patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MHR SIR; rapid antibiotic susceptibility testing by diffusion on MHR-SIR (Mueller-Hinton Rapid-SIR) medium from the blood culture bottle. Antibiotic susceptibility test results are obtained 7 hours after blood culture positivity	Diagnostic test: Antibiotic susceptibility testing; antibiotic susceptibility testing is performed on MHR-SIR or MH medium depending on randomization
Active Comparator: MH; Standard antibiotic susceptibility testing by diffusion on MH (Mueller-Hinton ) medium from the blood culture bottle Antibiotic susceptibility test results are obtained 24 hours after blood culture positivity	Diagnostic test: Antibiotic susceptibility testing; antibiotic susceptibility testing is performed on MHR-SIR or MH medium depending on randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective Antiobiotherapy	percentage of patients with Enterobacterales bacteremia for whom antibiotic therapy was effective against the incriminating bacterium within 12 hours of a positive blood culture, according to the results of the antibiogram.	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Frame	Time between blood sampling and antibiogram results	3days
Time necessary to modify the spectrum of probabilistic antibiotic therapy after the antibiogram results	in hours	2 days
time between the start of intravenous antibiotic therapy and oral antibiotics.	in days	1month
type of Antibiotherapy spectra modification	After obtaining the antibiogram result, was the antibiotherapy modified (Yes or No) and if yes, was it for narrowing the antibiotic spectra (yes or no)	2 days
length of hospital stay	In days,	1 month

Collaborators and Investigators

• Sponsor: Fondation Hôpital Saint-Joseph
• Investigators: Principal Investigator: Jean Claude NGUYEN VAN, MD, Fondation Hôpital Saint-Joseph

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2024
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): August 15, 2025

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: bacteremia; antibiogram
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 650-MHR Blood

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No