Inhaled colistin to prevent pneumonia in ventilated patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Qilu Hospital of Shandong university
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Hao Wang, Professor
• Email: wanghao34@126.com
• Phone: 18560081013

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Innate Immune Immunoparalysis and Ventilator-Associated Pneumonia in Critically Ill Elderly Patients

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• Using airway resistance changes to guide suctioning for ventilated patients

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• Early detection of ventilator-associated pneumonia in critically ill children using microbial and immune signatures.

  This project will test whether combining microbial genomic data and a child's immune-response signals can detect ventilator-associated pneumonia earlier in critically ill children on mechanical ventilation.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.