Inhaled colistin to prevent pneumonia in ventilated patients

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

This study is testing if inhaled colistin can help prevent pneumonia in patients on ventilators who are at high risk for infections.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 508 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06834971 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of inhaled colistin methanesulfonate sodium (CMS) in preventing ventilator-associated pneumonia (VAP) among patients on mechanical ventilation. It is a multicenter, double-blind, randomized, placebo-controlled trial that aims to administer a 3-day course of CMS to high-risk patients. The study focuses on patients who have been on mechanical ventilation for more than 48 hours and are at risk for multidrug-resistant bacterial infections. The trial seeks to determine if this intervention can significantly reduce the incidence of VAP, which is a serious complication in intensive care settings.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been on mechanical ventilation for more than 48 hours and have high-risk factors for multidrug-resistant infections.

Not a fit: Patients who are suspected or confirmed to have ventilator-associated pneumonia at the time of inclusion will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of ventilator-associated pneumonia, improving patient outcomes and reducing healthcare costs.

How similar studies have performed: Previous studies have indicated the effectiveness of colistin against multidrug-resistant organisms, suggesting potential success for this approach.

Eligibility criteria

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.

Where this trial is running

Jinan, Shandong

• Qilu Hospital of Shandong university — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Hao Wang, Professor

Conditions Ventilator-Associated Pneumonia; colistin; prevention; nebulization