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

Study acronym: MHR-Blood
StatusUnknown
PhaseNot applicable
Started
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Record status
This record was last updated September 27, 2024 (before its estimated July 15, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: May 15, 2025 to Jul 15, 2025
    • Study completion date: Jun 15, 2025 to Aug 15, 2025
    • Start date changed from estimate of Jun 15, 2024 to Aug 12, 2024
  3. Notable Primary endpoint revised
    • Interventions: Antibiotic susceptibiliy testing (Diagnostic Test) to Antibiotic susceptibility testing (Diagnostic Test)
    • Secondary endpoints revised (5)
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06425367
Lead Sponsor Fondation Hôpital Saint-Joseph
Conditions
(from sponsor)
Bacteremia
Related terms Bacteremia
Enrollment 960 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov