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临床试验/NCT03927079
NCT03927079进行中(未招募)不适用

Predictive Factors of Good Pulmonary Penetration of Antibiotics : AntiBiotics Dosage in Broncho-Alveolar Lavage

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2019年4月23日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
101
试验地点
1
主要终点
pulmonary diffusion level for beta lactamins

研究概览

简要总结

Respiratory infections are common and sometimes very severe. An insufficient dosage of the antibiotic could lead to a treatment failure A correct plasmatic antibiotic concentration is not a guarantee of a clinical success as it could not be a reflect of pulmonary concentration. The aim of this study is to determinate the predictive factors of pulmonary penetration of antibiotics in patients with a beta lactamines failure and who undergoes a flexible bronchoscopy.

详细描述

To check if pulmonary concentrations of antibiotic are enough we will measure antibiotic concentration in the broncho-alveolar lavage (BAL). This technique which is clinically relevant and reliable could determinate the pulmonary diffusion level for antibiotics by calculating the ratio between plasmatic and intra-alveolar antibiotic concentration. This ratio will be correlated with potential limitation factors of pulmonary diffusion as respiratory diseases (COPD, cystic fibrosis, fibrosis…), sepsis, hypoalbuminemia. We have chosen to study the beta lactamin antibiotics because they are the most frequently used in pneumonia. Moreover, the beta lactamins pulmonary diffusion is likely to be the lowest. Finally, for patients with a known pathogen, we will divide this pulmonary concentration with minimal inhibitory concentration (MIC). Indeed, in severe pneumonia, to be sure of bactericidal activity, a pulmonary concentration of beta lactamines should be always higher than 4 to 5 times MIC.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • patients who undergo a flexible bronchoscopic lavage and with a beta lactamines treatment as cephalosporin of 3rd generation (CEFTRIAXONE / CEFOTAXIME, CEFTAZIDIME), of 4th generation (CEFEPIM), or AMOXICILLIN-CLAVULANIC ACID, or PIPERACILLIN-TAZOBACTAM
  • patient major
  • informed and signed consent form

排除标准

  • patient under chronic dialysis
  • patient placed under judicial protection

结局指标

主要结局

pulmonary diffusion level for beta lactamins

时间窗: on the day of the bronco-alveolar lavage

pulmonary diffusion level for beta lactamins is determined by ratio between bronchoalveolar concentration and plasmatic concentration of tested antibiotics

次要结局

  • duration in days for regression of the biological inflammatory syndrome(from day of inclusion to 15 days after inclusion)
  • measure of length of hospitalisation(from day of inclusion to 15 days after inclusion)
  • Number of deaths at 28-day(28 days after inclusion)
  • virus presence in BAL(day of bronchoalveolar lavage (BAL))
  • measure of apyrexia duration in days(from day of inclusion to 15 days after inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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