An interventional study of Antibiotic susceptibility testing in Bacteremia, sponsored by Fondation Hôpital Saint-Joseph. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Fondation Hôpital Saint-Joseph · Not applicable, Interventional, and Diagnostic
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.
297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.
This study's planned enrollment of 960 is above the median of 156 across 156 interventional studies indexed under Bacteremia.
Browse Bacteremia studies →Fondation Hôpital Saint-Joseph is the lead sponsor of 346 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
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
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
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.
Time frame: 12 hours
Time Frame
Time between blood sampling and antibiogram results
Time frame: 3days
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)
Time frame: 2 days
Time necessary to modify the spectrum of probabilistic antibiotic therapy after the antibiogram results
in hours
Time frame: 2 days
time between the start of intravenous antibiotic therapy and oral antibiotics.
in days
Time frame: 1month
length of hospital stay
In days,
Time frame: 1 month
Plan to share: No
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