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

Ventilator-associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06076603
• Other study ID #: PMBPIN
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: October 2023
• Source: Southeast University, China
• Contact: Yingzi Huang, MD
• Phone: +86-025-83262552
• Email: yz_huang[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• Bacterial Infections
• Pneumonia
• Pneumonia, Ventilator-Associated
• Polymyxin B
• Ventilator-associated Pneumonia

Intervention

Drug:
• nebulized polymyxin B
The experimental group received intravenous combined nebulization of polymyxin B

Locations

Country	Name	City	State
China	Zhongda Hospital Affiliated to Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood concentration	Blood concentration	3 days after the end of the patient's first medication use
Primary	ELF concentration	Drug concentration in ELF solution	3 days after the end of the patient's first medication use
Secondary	28-day clinical cure rate	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 days after the end of the patient's medication
Secondary	28-day microbiological cure rate	the proportion of subjects of microbiological cure to the number of subjects in each group 28 days after treatment with polymyxin B.	28 days after the end of the patient's medication
Secondary	28-day adverse reaction rate	the proportion of subjects who experienced adverse reactions within 28 days after treatment with polymyxin B to the number of subjects in each group	28 days after the end of the patient's medication