Jet versus vibrating mesh inhalation of polymyxin B for ventilated patients with carbapenem‑resistant Gram‑negative pneumonia
A Prospective Clinical Study on Different Methods of Aerosolized Polymyxin B Inhalation for the Treatment of Carbapenem-Resistant Gram-Negative Bacterial Pneumonia
Fujian Medical University Union Hospital · NCT07086391
This trial tests whether jet nebulizers or vibrating mesh nebulizers deliver inhaled polymyxin B more effectively for mechanically ventilated patients with carbapenem‑resistant Gram‑negative pneumonia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Fujian Medical University Union Hospital (other) |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT07086391 on ClinicalTrials.gov |
What this trial studies
This randomized, open‑label, parallel‑group trial will enroll 144 mechanically ventilated patients with culture‑confirmed carbapenem‑resistant Gram‑negative pneumonia and randomize them 1:1 to jet or vibrating mesh nebulization of 25 mg polymyxin B in 5 ml sterile water. Ventilator settings are standardized (SIMV+PSV, tidal volume 8 ml/kg, PEEP 6 cmH2O) and both groups receive adjunctive intravenous polymyxin B starting 12 hours after nebulization (2.0 mg/kg loading dose, then 1.25 mg/kg every 12 hours) for a total of 14 days. Bronchoalveolar lavage fluid and blood are collected at baseline and one hour after nebulization to compare pulmonary deposition and systemic exposure and to monitor safety. The trial is single‑center at Fujian Medical University Union Hospital and uses clinical, microbiologic, and pharmacokinetic data to compare the two nebulization methods.
Who should consider this trial
Good fit: Mechanically ventilated adults with radiographic and clinical pneumonia and sputum culture confirming carbapenem‑resistant Gram‑negative bacteria susceptible to polymyxin B, who can receive at least three days of aerosolized therapy and provide consent, are ideal candidates.
Not a fit: Patients who are not mechanically ventilated, have polymyxin‑resistant organisms, severe liver or kidney failure, or a life expectancy under 48 hours are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, one nebulizer method could deliver higher lung drug concentrations and lead to faster bacterial clearance with less systemic toxicity.
How similar studies have performed: Previous pharmacokinetic and clinical reports support inhaled polymyxins to increase lung drug levels in ventilated patients, but randomized comparisons of jet versus vibrating mesh nebulizers are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pneumonia diagnosed per Chinese Thoracic Society criteria (radiographic + clinical evidence). * Sputum culture-confirmed carbapenem-resistant Gram-negative bacteria susceptible to polymyxin B. * ≥3 days of aerosolized polymyxin B therapy. * Mechanically ventilated with an artificial airway. Exclusion Criteria: * Polymyxin B aerosol use planned for \<3 days. * Terminal status (life expectancy \<48h). * Severe liver/kidney dysfunction (ALT/AST \>5× ULN; eGFR \<30 mL/min). * No informed consent.
Where this trial is running
Fuzhou, Fujian
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (RECRUITING)
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.
Conditions: Carbapenem-Resistant Enterobacteriaceae Infection, Pneumonia - Bacterial