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

NCT06834971 · tracked via the Priya Life Science China tracker

Sponsor

Qilu Hospital of Shandong University

Phase

Not applicable

Started

2025-07-15

Last updated

2026-05-19

Condition(s) studied

Ventilator-Associated Pneumonia (VAP)

Investigational drug(s) / intervention(s)

Colistimethate sodium (CMS) →

Colistimethate sodium (CMS): CMS (colistimethate sodium, 75mg, solubilized in 4 mL 0.9% saline), twice daily. Nebulization will be performed using a vibrating mesh nebulizer (Aeroneb solo, Aerogen, Galway, Ireland) placed in the inspiratory limb of the ventilator tubing, behind the Y-piece, and continued until the nebulizer deposit becomes dry for three consecutive days of mechanical ventilation. To ensure the experiment is conducted under blind conditions, the Nebulizer will be covered by stickers. A filter will be placed on the expiratory limb to protect the ventilator.

Study summary

Previous studies have identified Acinetobacter baumannii (AB), Pseudomonas aeruginosa (PA), and Klebsiella pneumoniae (KP) as the predominant pathogens responsible for ventilator-associated pneumonia (VAP). The challenge of drug resistance, especially against carbapenem is intensifying, with variations noted across different regions. Multidrug-resistant organisms associated VAP (MDR-VAP) are increasing in frequency and are associated with significant morbidity, mortality, therefore imposes a heavy burden on the healthcare system. Colistin methanesulfonate sodium (CMS) has shown effectiveness against gram-negative bacteria, including carbapenem-resistant organisms (CRO) such as carbapenem-resistant Acinetobacter baumannii (CRAB), carbapenem-resistant Pseudomonas aeruginosa (CRPA), and carbapenem-resistant Klebsiella pneumoniae (CRKP). This trial aims to evaluate the efficacy of a 3-day course of inhaled CMS in lowering the incidence of VAP among patients undergoing invasive mechanical ventilation for at least two days and at high risk of MDR-VAP.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Participants will be enrolled if they meet the following criteria: 1. Age ≥18 years; 2. Mechanical ventilation for more than two consecutive days (48 hours); 3. Patient has high-risk factors for multidrug-resistant bacterial infections, which meet any of the following criteria: (1)History of antibiotic exposure within 30 days; (2)Hospitalization time\>5 days (120 hours); (3)Septic shock; (4) ARDS; (5)Accept renal replacement therapy; (6)Previous colonization of multidrug-resistant bacteria; 4. Informed consent of the patient or a proxy was written. Participants will be excluded in case of: 1. Suspected or confirmed VAP at the inclusion day; 2. Patient ventilated through an endotracheal tube for more than four consecutive days (96 hours); 3. Expected that endotracheal intubation will be removed within the next 24 hours; 4. Tracheostomy; 5. Allergy to CMS; 6. Patients has polymyxins medication history within 7 days or clinical indication for systemic CMS therapy at the inclusion day; 7. Chronic kidney failure with baseline glomerular filtration ≤30 mL/min or Stage 3 classification AKI (KDIGO) (excluding patients undergoing renal replacement therapy); 8. Expected survival time not exceeding 48 hours; 9. Pregnancy or breastfeeding period; 10. Patients previously included in this study or are using any inhaled antibiotics or are participating in other clinical studies within 30 days.

Primary outcome measure(s)

The incidence of a first VAP episode from randomization to day 28 — from randomization to day 28
calculated as the ratio of the number of patients diagnosed VAP divided by the number of randomized patients in each group

Trial sites (1)

Facility	City	Region	Status
Qilu Hospital of Shandong university	Jinan	Shandong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06834971 on ClinicalTrials.gov ↗ ← All trials in China