Hôpital Paris Saint Joseph
Paris, France
Location status: Recruiting
Location contact
Helene BEAUSSIER
CONTACT
Jean-claude NGUYEN VAN, pharmaD
CONTACT
Juliette COURTIADE MAHLER
CONTACT
NCT Number: NCT06425367
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Paris, France
Location status: Recruiting
Helene BEAUSSIER
CONTACT
Jean-claude NGUYEN VAN, pharmaD
CONTACT
Juliette COURTIADE MAHLER
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
antibiotic susceptibility testing is performed on MHR-SIR or MH medium depending on randomization
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.
Time frame: 3days
Time between blood sampling and antibiogram results
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)
Time frame: 2 days
in hours
Time frame: 1month
in days
Time frame: 1 month
In days,
Contact information is provided by the study sponsor or research team.
Helene BEAUSSIER
CONTACT
Juliette COURTIADE MAHLER
CONTACT
Fondation Hôpital Saint-Joseph
Other
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
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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