Comparing intravenous and nebulized polymyxin B for pneumonia treatment
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
This study is testing whether using a combination of intravenous and nebulized polymyxin B can help people with pneumonia caused by tough bacteria feel better compared to just using the intravenous treatment alone.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Southeast University, China Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06076603 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of intravenous polymyxin B combined with nebulization in treating patients with multidrug-resistant bacteria causing ventilator-associated pneumonia. Participants will be divided into two groups based on whether they receive nebulization therapy, and samples of blood and alveolar lavage fluid will be collected to measure drug concentrations. The study seeks to determine if nebulization enhances antimicrobial efficacy and improves clinical outcomes compared to intravenous treatment alone.
Who should consider this trial
Good fit: Ideal candidates are ICU patients aged 18-80 with multidrug-resistant ventilator-associated pneumonia who can tolerate the treatment regimen.
Not a fit: Patients with severe hypersensitivity to polymyxin B, those unable to undergo alveolar lavage, or those with certain malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients suffering from multidrug-resistant pneumonia.
How similar studies have performed: While the specific combination of intravenous and nebulized polymyxin B is novel, similar studies have shown promise in enhancing treatment for multidrug-resistant infections.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Nanjing, Jiangsu
- Zhongda Hospital Affiliated to Southeast University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Yingzi Huang, MD
- Email: yz_huang@126.com
- Phone: +86-025-83262552
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.