Multidrug Resistant Bacterial Infection, Pharmacogenomic Drug Interaction, Polymyxin B, Ventilator-associated Pneumonia
Conditions
Brief summary
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.
Interventions
DRUGnebulized polymyxin B
The experimental group received intravenous combined nebulization of polymyxin B
Sponsors
Southeast University, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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;
Exclusion criteria
* 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood concentration | 3 days after the end of the patient's first medication use | Blood concentration |
| ELF concentration | 3 days after the end of the patient's first medication use | Drug concentration in ELF solution |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-day clinical cure rate | 28 days after the end of the patient's medication | the proportion of subjects who are thought as clinical effectiveness 28 days after treatment with polymyxin B to the number of subjects in each group. |
| 28-day microbiological cure rate | 28 days after the end of the patient's medication | the proportion of subjects of microbiological cure to the number of subjects in each group 28 days after treatment with polymyxin B. |
| 28-day adverse reaction rate | 28 days after the end of the patient's medication | the proportion of subjects who experienced adverse reactions within 28 days after treatment with polymyxin B to the number of subjects in each group |
Countries
China
Contacts
Primary ContactYingzi Huang, MD
Backup ContactJianfeng Xie, MD
Outcome results
None listed