Идёт набор NCT06425367

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

Без фазы С лечением Bacteremia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Antibiotic susceptibility testing.
Кому может быть актуально: Состояния в реестре: Bacteremia. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

Effective Antiobiotherapy [Срок оценки: 12 hours]

Вторичные конечные точки (5)

Time Frame [Срок оценки: 3days]
type of Antibiotherapy spectra modification [Срок оценки: 2 days]
Time necessary to modify the spectrum of probabilistic antibiotic therapy after the antibiogram results [Срок оценки: 2 days]
time between the start of intravenous antibiotic therapy and oral antibiotics. [Срок оценки: 1month]
length of hospital stay [Срок оценки: 1 month]

Критерии участия

Критерии включения

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