Informations générales (source: ClinicalTrials.gov)
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 (MHR-Blood)
Interventional
N/A
Fondation Hôpital Saint-Joseph (Voir sur ClinicalTrials)
août 2024
août 2025
28 septembre 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Helene BEAUSSIER | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- Patients with non-enterobacterial bacteremia
- Patient under guardianship
- Patient deprived of liberty
- Patient under court protection
- Pregnant or breast-feeding patient