Inhaled Colistin Methanesulfonate Sodium to Prevent Ventilator-Associated Pneumonia in Adults on Mechanical Ventilation A Multicenter, Double-Blind, Randomized Trial

What this Trial Is About

Ventilator-Associated Pneumonia VAP is a serious infection that develops in patients who have been on mechanical ventilation for 48-72 hours or more, often leading to increased illness and longer hospital stays. This research aims to evaluate whether a 3-day course of inhaled colistin methanesulfonate sodium CMS can lower the incidence of VAP, especially caused by multidrug-resistant bacteria, in patients on invasive mechanical ventilation for at least two days and considered high risk for this infection. The study responds to the growing challenge of drug-resistant bacteria such as carbapenem-resistant Acinetobacter baumannii, Pseudomonas aeruginosa, and Klebsiella pneumoniae. Participants are randomly assigned to receive either inhaled CMS or a placebo saline solution twice daily for three days. The medication is delivered using a vibrating mesh nebulizer connected to the ventilator tubing, ensuring blinded administration during the treatment period. The study is conducted across multiple centers and uses a double-blind, placebo-controlled design to compare the effects of CMS inhalation against placebo in preventing VAP. During the study, participants are closely monitored for the development of VAP and multidrug-resistant VAP from the time of randomization through 28 days. Researchers will track various outcomes including the incidence of pneumonia, days on mechanical ventilation, antibiotic use, length of ICU and hospital stay, mortality rates at 28 and 90 days, and any side effects related to the nebulized treatment. Safety assessments and microbiological evaluations are also performed to check for resistant bacteria. The total follow-up period extends up to 90 days for some outcomes, ensuring a comprehensive assessment of the interventions impact.

Colistin Methanesulfonate Sodium Inhalation for Prophylaxis of Ventilator-Associated Pneumonia (CIVAP): A Prospective, Multicentre, Double-Blind, Randomized, Placebo-Controlled Trial