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临床试验/NCT05464680
NCT05464680已完成不适用

Pulmonary Diffusion of Antibiotics During Mechanically Ventilated Pneumonia in Patients Admitted for ARDS Following SARS-CoV-2 Pneumonia

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Compare the pulmonary diffusion of piperacillin

研究概览

简要总结

Patients on mechanical ventilation (MV) following SARS-CoV-2 pneumonia frequently develop ventilator-associated pneumonia (VAP). The incidence of MVAP during SARS-CoV-2 infections ranges from 50 to nearly 90%. In addition, up to 80% of recurrences of VAP (a new episode, most often attributable to the same bacteria) have been described, reflecting the failure of the initial antibiotic therapy. This incidence is much higher than that described for other etiologies of acute respiratory distress syndrome (ARDS). The investigators hypothesize that during VAP, there is an alteration of the diffusion of intravenous antibiotics in the lung parenchyma in COVID-19 patients in relation to several factors characteristic of SARS-CoV-2 infection. This altered diffusion may explain the high number of recurrences of MVAP compared to non-COVID-19 patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

  • 1. Patient over 18 years of age
  • Patient has given consent or consent obtained from the trusted person if the patient is not capable of consenting, after informed consent.
  • 3. Patient with ARDS
  • Patient requiring MV for ARDS (as defined by Berlin (15)), regardless of etiology (COVID-19 or other cause of ARDS)
  • Patient with suspected 1st episode of ARDS for which microbiological sampling is performed (bronchial aspiration, protected distal sampling (PDS), bronchoalveolar lavage (BAL))
  • Patients who have received probabilistic antibiotic therapy within 24 hours of the microbiological sample, including piperacillin-tazobactam (PIP-TAZ) administered according to current recommendations.
  • 7. Patient who is a beneficiary of or affiliated to a social security system

排除标准

  • Patients for whom PIP-TAZ is administered as a discontinuous infusion.
  • Contraindication to the realization of a mini-LBA: patient whose respiratory state is too precarious for the realization of a mini-LBA for intra pulmonary antibiotics dosage (SpO2<94% under FiO2 100% under VM), presence of a non drained pneumothorax, bronchial prosthesis, recent bronchial suture
  • Patient with a second episode of PAVM.
  • Patients with KDIGO stage ≥ 3 renal failure or extra-renal replacement therapy (creatinine measurement on the day of inclusion, performed as part of routine care).
  • Patient on ExtraCorporeal Membrane Oxygenation (ECMO) or ExtraCorporeal CO2 Removal (ECCO2R).
  • Pregnant or breastfeeding women, patients under guardianship or trusteeship, deprived of liberty
  • Patients who are moribund or for whom limitations of active therapies have been decided.
  • Any condition, which in the opinion of the investigator, would not allow the implementation of the study procedures.

结局指标

主要结局

Compare the pulmonary diffusion of piperacillin

时间窗: 48 hours following antibiotics administration

Dosage in the epithelial lining fluid

次要结局

  • Pulmonary diffusion of tazobactam(48 hours following antibiotics administration)
  • Concentrations of tazobactam in effective pulmonary and plasma targets(48 hours following antibiotics administration)
  • Concentrations of piperacillin in effective pulmonary and plasma targets(7 days following antibiotics administration)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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