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NCT Number: NCT06425367

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic susceptibility testing

Diagnostic Test

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

Primary outcomes

  1. Effective Antiobiotherapy

    Time frame: 12 hours

    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.

Secondary outcomes

  1. Time Frame

    Time frame: 3days

    Time between blood sampling and antibiogram results

  2. type of Antibiotherapy spectra modification

    Time frame: 2 days

    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)

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

    Time frame: 2 days

    in hours

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

    Time frame: 1month

    in days

  5. length of hospital stay

    Time frame: 1 month

    In days,

Study contacts

Contact information is provided by the study sponsor or research team.

Helene BEAUSSIER

CONTACT

[email protected]

+33144127038

Juliette COURTIADE MAHLER

CONTACT

[email protected]

+33144127963

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Official study title

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

Acronym: MHR-Blood

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 22, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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