Jet versus vibrating mesh inhalation of polymyxin B for ventilated patients with carbapenem‑resistant Gram‑negative pneumonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.