Actively Recruiting
Different Methods of Aerosolized Polymyxin B Inhalation for Treating Carbapenem-Resistant Gram-Negative Bacterial Pneumonia
Led by Fujian Medical University Union Hospital · Updated on 2025-07-25
144
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates different methods of delivering aerosolized polymyxin B to treat patients with carbapenem-resistant Gram-negative bacterial pneumonia who require mechanical ventilation. It aims to compare the effectiveness and safety of two nebulization techniques in this serious lung infection. This research will enroll 144 patients and evaluate their response to these treatments over time. Participants are randomly assigned to receive 25mg polymyxin B dissolved in sterile water via either a jet nebulizer or a vibrating mesh nebulizer, both assisted by respirators. In addition, all participants receive intravenous polymyxin B with a loading dose followed by maintenance doses every 12 hours, starting 12 hours after nebulization. The treatment lasts for 14 days, with ventilator settings standardized during nebulization. Throughout the study, daily monitoring includes vital signs, sputum volume, and ventilator parameters. Bronchoalveolar lavage fluid and blood samples are collected before treatment, one hour after nebulization, and during days 3 to 7 to measure drug concentration and inflammatory markers. Blood tests and sputum cultures occur at baseline and on days 3, 7, and 14. Researchers assess clinical efficacy, survival over 28 days, bacterial clearance, inflammatory response, and safety indicators such as kidney function and airway complications.
CONDITIONS
Brief Title
Different Methods of Aerosolized Polymyxin B Inhalation for Treating Carbapenem-Resistant Gram-Negative Bacterial Pneumonia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pneumonia diagnosed according to Chinese Thoracic Society criteria with radiographic and clinical evidence
- Sputum culture confirming carbapenem-resistant Gram-negative bacteria sensitive to polymyxin B
- At least 3 days of aerosolized polymyxin B therapy
- Currently mechanically ventilated with an artificial airway
You will not qualify if you...
- Planned use of polymyxin B aerosol for less than 3 days
- Terminal condition with life expectancy under 48 hours
- Severe liver dysfunction with ALT or AST levels more than 5 times the upper limit of normal
- Severe kidney dysfunction with estimated glomerular filtration rate below 30 mL/min
- Lack of informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 3 days
Participants receive aerosolized polymyxin B via either jet nebulizer or vibrating mesh nebulizer while on mechanical ventilation.
Daily visits during aerosolized polymyxin B therapy
Duration - Up to 28 days
Participants are observed for clinical efficacy, survival, and microbiological clearance up to 28 days after starting treatment.
Follow-up visits up to Day 28 after treatment start
Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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