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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06425367
Acronym
MHR-Blood
Enrollment
960
Registered
2024-05-22
Start date
2024-08-12
Completion date
2025-08-15
Last updated
2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteremia

Keywords

antibiogram, bacteremia

Brief summary

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.

Interventions

DIAGNOSTIC_TESTAntibiotic susceptibility testing

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

Sponsors

Fondation Hôpital Saint-Joseph
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Intervention model description

cluster cross-over randomized trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effective Antiobiotherapy12 hourspercentage 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

MeasureTime frameDescription
Time Frame3daysTime between blood sampling and antibiogram results
type of Antibiotherapy spectra modification2 daysAfter 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 necessary to modify the spectrum of probabilistic antibiotic therapy after the antibiogram results2 daysin hours
time between the start of intravenous antibiotic therapy and oral antibiotics.1monthin days
length of hospital stay1 monthIn days,

Countries

France

Contacts

Primary ContactHelene BEAUSSIER
crc@ghpsj.fr+33144127038
Backup ContactJuliette COURTIADE MAHLER
jcourtiade@ghpsj.fr+33144127963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026