An interventional study of Inhaled colistin and Inhaled 0.9% sodium chloride in Ventilator-Associated Pneumonia (VAP) and Inha'le'd, sponsored by Southeast University, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Southeast University, China · Not applicable, Interventional, and Prevention
Ventilator associated pneumonia is the most common manifestation of hospital acquired infections in ICU. The incidence of ventilator-associated pneumonia in patients receiving mechanical ventilation is as high as 20% -71%, which can lead to increased systemic antibiotic use, prolonged mechanical ventilation time and ICU stay, and increased treatment costs. In addition, ventilator-associated pneumonia is also the main cause of hospital infection related deaths in critically ill patients.
However, there is a certain buffer time for patients to develop ventilator-associated pneumonia after receiving endotracheal intubation. Previous studies have found that the peak incidence occurs after 7 days of mechanical ventilation, so there is an opportunity for early treatment to prevent infection. Despite the implementation of numerous preventive measures for ventilator-associated pneumonia over the decades, such as reducing sedation and withdrawal protocols, patient positioning, oral care, prophylactic probiotics, prophylactic antibiotics, and the use of silver plated endotracheal tubes. Among them, the research on the preventive use of antibiotics has a history of over 30 years and is a topic of substantial debate. Prophylactic use of antibiotics includes systemic application and local nebulization inhalation, and inhaled antibiotics may be an effective measure for preventing ventilator-associated pneumonia. Potential extensively drug-resistant Gram negative (XDR-GN) bacteria, such as Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii, are common pathogens causing VAP in ICU. The mortality rate of VAP caused by XDR-GN pathogen may be higher than 70%. With the increasing incidence of multidrug-resistant microorganisms, nebulized or inhaled aminoglycoside antibiotics are often used as empirical or definitive treatment for VAP in ICU patients. The previous group of antibiotics, polymyxin, has returned to the view of medical staff. Sodium polymyxin E methanesulfonate has been used as a salvage therapy for XDR-GN bacteria causing pneumonia, demonstrating its activity against XDR-GN causing VAP in critically ill patients. The guidelines of the Infectious Diseases Society of America (IDSA) on hospital acquired pneumonia also indicate that patients with Gram negative pneumonia caused by drug-resistant bacteria are sensitive to polymyxins. In this randomized controlled study, we aim to investigate the effect of prophylactic use of polymyxin E nebulized inhalation on the incidence of VAP.
420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 85 are open to participants now.
This study's planned enrollment of 444 is above the median of 115 across 276 interventional studies indexed under Pneumonia, Ventilator-Associated.
Browse Pneumonia, Ventilator-Associated studies →Southeast University, China is the lead sponsor of 168 studies on the registry; 45 are open to participants now.
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Exclusion Criteria:
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nebulization was initiated within 24 hours after patient enrollment. Experimental group received nebulization with colistin (75 mg per dose） twice daily for 3 consecutive days with a vibrating mesh nebulizer.
Drug: Inhaled colistin
Nebulization was initiated within 24 hours after patient enrollment. Control group received nebulization with an equivalent volume of 0.9% sodium chloride twice daily for 3 consecutive days with a vibrating mesh nebulizer.
Drug: Inhaled 0.9% sodium chloride
Colistin powder will be solubilised in 0.9% Nacl (75mg per 5 mL)， and used for nebulisation twice a day at a dose of 75mg for 3 days
Saline solution of 0.9% sodium chloride (NaCl) will be used as placebo. The equivalent volume of 0.9% NaCl will be placed in the nebuliser and delivered twice a day for 3 days.
Prevention of early VAP
the incidence of VAP within 7 days after randomisation
Time frame: From randomization to 7 days
VAP incidence within 28 days
The incidence of VAP within 28 days after randomisation
Time frame: From randomization to 28 days
Use of systemic antibiotic
The number of days of systemic antibiotic use and the daily dose of antibiotics administered within 28 days after randomization.
Time frame: From randomization to day 28
Success of SBT
The number of days from randomization to the first successful spontaneous breathing test (SBT).
Time frame: From randomization to first success of SBT
Invasive ventilator-free days at 28 days
Days alive without endotracheal intubation and invasive mechanical ventilation
Time frame: From randomization to 28 days
Successful weaning from mechanical ventilation
The proportion of patients who were successfully weaned from mechanical ventilation within 28 days after randomisation.
Time frame: From randomization to 28 days
ICU days at day 28
The number of ICU days within 28 days after randomization
Time frame: From randomization to 28 days
Hospital days at day 28
The number of Hospital days within 28 days after randomization
Time frame: From randomization to 28 days
28-day mortality
The proportion of patients who died within 28 days
Time frame: From randomization to 28 days
Incidence of AKI
The proportion of patients who were newly diagnosed acute kidney injury (AKI) within 28 days after randomization, defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria.
Time frame: From randomization to day 28
Plan to share: No
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Started Apr 2025 (actual). Primary completion is estimated for Dec 2026, 20 months after the start.
Of 81 non-industry interventional studies with no phase under Pneumonia, Ventilator-Associated, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 20 months is close to that.
Counting every sponsor, half of 82 studies reached it within 20 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Colistin
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