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临床试验/NCT06425367
NCT06425367尚未招募不适用

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

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 960 人开始时间: 2024年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
960
试验地点
1
主要终点
Effective Antiobiotherapy

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients with non-enterobacterial bacteremia
  • Patient under guardianship
  • Patient deprived of liberty
  • Patient under court protection
  • Pregnant or breast-feeding patient

结局指标

主要结局

Effective Antiobiotherapy

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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