Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06834971

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

Led by Qilu Hospital of Shandong University · Updated on 2025-07-15

508

Participants Needed

1

Research Sites

72 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Mechanical ventilation for more than two consecutive days (48 hours)
  • High risk for multidrug-resistant bacterial infection, including any of these: recent antibiotic use within 30 days, hospitalization longer than 5 days, septic shock, ARDS, receiving renal replacement therapy, or previous multidrug-resistant bacteria colonization
  • Written informed consent by the patient or proxy
Not Eligible

You will not qualify if you...

  • Suspected or confirmed ventilator-associated pneumonia at enrollment
  • Mechanical ventilation through an endotracheal tube for more than four consecutive days (96 hours)
  • Expected removal of endotracheal tube within 24 hours
  • Presence of tracheostomy
  • Allergy to colistimethate sodium
  • Use of polymyxins within 7 days or systemic CMS therapy needed at enrollment
  • Chronic kidney failure with glomerular filtration rate ≤30 mL/min or Stage 3 acute kidney injury (except if on renal replacement therapy)
  • Expected survival less than 48 hours
  • Pregnancy or breastfeeding
  • Previous participation in this study, use of inhaled antibiotics, or enrollment in other clinical trials within 30 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Qilu Hospital of Shandong university

Jinan, Shandong, China, 250000

Actively Recruiting

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Research Team

H

Hao Wang, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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