Impact of Performing a Rapid Antibiotic Susceptibility Test on Antibiotic Therapy Adaptation in Adult Patients with Enterobacterales Bacteremia

NCT06425367 | Recruiting

• 1 other identifier: 650-MHR Blood
• Study Type: interventional
• Target: 960
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacteremia

Keywords

antibiogram; bacteremia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time Frame

  3days

• type of Antibiotherapy spectra modification

  2 days

• Time necessary to modify the spectrum of probabilistic antibiotic therapy after the antibiogram results

  2 days

• time between the start of intravenous antibiotic therapy and oral antibiotics.

  1month

• length of hospital stay

  1 month

Study Arms (2)

MHR SIR

EXPERIMENTAL

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

MH

ACTIVE COMPARATOR

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

Interventions

Antibiotic susceptibility testing DIAGNOSTIC_TEST

antibiotic susceptibility testing is performed on MHR-SIR or MH medium depending on randomization

MH; MHR SIR

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Hôpital Paris Saint Joseph

Paris, France

RECRUITING

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean Claude NGUYEN VAN, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helene BEAUSSIER

CONTACT

+33144127038; crc@ghpsj.fr

Juliette COURTIADE MAHLER

CONTACT

+33144127963; jcourtiade@ghpsj.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cluster cross-over randomized trial

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start: August 12, 2024
• Primary Completion: July 15, 2025
• Study Completion: August 15, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)