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Different Methods of Aerosolized Polymyxin B Inhalation for Treating Carbapenem-Resistant Gram-Negative Bacterial Pneumonia.

Recruitingn/aAges 18 Years - 90 YearsAllFujian Medical University Union Hospital
NCT07086391 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Study Design: A randomized, open-label, parallel-group clinical trial comparing the efficacy and safety of jet nebulization versus vibrating mesh nebulization of sulfate polymyxin B in mechanically ventilated patients with carbapenem-resistant Gram-negative bacterial pneumonia. Participants: 144 patients (72 per group) will be enrolled from December 2023 to December 2025. Interventions: Group A: 25mg polymyxin B + 5ml sterile water via jet nebulizer (respirator-assisted). Group B: 25mg polymyxin B + 5ml sterile water via vibrating mesh nebulizer (respirator-assisted). Both groups receive additional intravenous polymyxin B (2.0mg/kg loading dose, followed by 1.25mg/kg every 12h) starting 12h after nebulization. Treatment duration: 14 days. Key Procedures: Nebulization parameters: Fixed ventilator settings (SIMV+PSV mode, tidal volume 8ml/kg, PEEP 6cmH₂O). Bronchoalveolar lavage

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📋 Eligibility rules (as published)
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.
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What it tests

  • Polymyxin B Sulfate 25mg Jet Nebulization / Vibrating Mesh Nebulization
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Where

1 site
Fujian Medical University Union Hospital
Fuzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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