Clinical Study Comparing Jet Nebulizer and Vibrating Mesh Nebulizer Delivery of Polymyxin B for Treating Resistant Gram-Negative Bacterial Pneumonia in Mechanically Ventilated Patients

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.

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