Comparison of Epithelial Lining Fluid and Blood Pharmacokinetics and Pharmacodynamics of Intravenous and Intravenous Plus Nebulized Polymyxin B in Multidrug Resistant Bacteria Ventilator-associated Pneumonia Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Blood concentration
研究概览
简要总结
The goal of this observational study is to investigate whether intravenous polymyxin B combined with nebulisation achieves better antimicrobial efficacy and clinical outcomes than intravenous use alone in patients with multidrug-resistant gram-negative bacilli infected with ventilator-associated pneumonia. The main questions it aims to answer are:
- When using intravenous polymyxin B to treat patients with ventilator-associated pneumonia caused by multidrug-resistant bacteria in clinical practice, is it necessary to assist with polymyxin B nebulization therapy？
- If necessary, how much dose of nebulization is better? Participants will be divided into two groups based on whether they have received nebulization treatment with polymyxin B in clinical practice. Blood and alveolar lavage fluid samples will be collected after the first dose injection and reaching the steady-state dose, and the drug concentration differences in blood and ELF will be measured in patients who have received intravenous injection of polymyxin B alone and those who have received adjuvant nebulization of polymyxin B, as well as differences in clinical outcomes and side effects.
Researchers will compare the differences in blood and ELF drug concentrations, clinical outcomes, and incidence of side effects between two groups of patients, to see if is it necessary to assist with polymyxin B nebulization therapy in patients with multidrug-resistant gram-negative bacilli infected with ventilator-associated pneumonia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old;
- •ICU patients;
- •Patients with MDR-infected VAP were diagnosed by etiological culture results;
- •Expect to receive at least 6 doses (3 days) of polymyxin B;
- •Obtain informed consent;
排除标准
- •The patient has a history of severe hypersensitivity to polymyxin B;
- •Patients cannot tolerate alveolar lavage;
- •Oncology patients,includes hematologic malignancies;
- •Pregnant or lactating women;
- •Patients with other conditions that the investigators consider unsuitable for enrollment;
研究组 & 干预措施
Intravenous combined with nebulized polymyxin B
The intravenous combined nebulization patient group was divided into two subgroups based on the different doses received -25mg q12h and 50mg q12h. Patients in the intravenous combination nebulized polymyxin B group received a total medication dose of 1.25 to 1.5mg/kg, of which 25-50mg was used for nebulization and the remaining portion was used for intravenous administration. The specific method of nebulization is to receive nebulized bronchodilator 30 minutes before nebulization, add 25-50mg of polymyxin B to 5ml of physiological saline for dilution, use a vibrating mesh nebulizer to connect to the patient's ventilator pipeline suction tube, do not change the original ventilator parameter settings, and continue nebulization for 30 minutes. After 30 minutes, regardless of whether there is any residue of the nebulized drug, it will be discarded according to general nursing methods.
干预措施: nebulized polymyxin B (Drug)
结局指标
主要结局
Blood concentration
时间窗: 3 days after the end of the patient's first medication use
Blood concentration
ELF concentration
时间窗: 3 days after the end of the patient's first medication use
Drug concentration in ELF solution
次要结局
- 28-day microbiological cure rate(28 days after the end of the patient's medication)
- 28-day adverse reaction rate(28 days after the end of the patient's medication)
- 28-day clinical cure rate(28 days after the end of the patient's medication)
研究者
Jianfeng Xie
MD.PhD
Southeast University, China