Ventilator-Associated Pneumonia (VAP)NCT06819462
Inhaled Colistin to Prevent Ventilator-Associated Pneumonia in Patients With Acute Brain Injury
A study testing Inhaled colistin and Inhaled 0.9% sodium chloride in people with Ventilator-Associated Pneumonia (VAP) and Inha'le'd, run by Southeast University, China at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventilator-Associated Pneumonia (VAP), Inha'le'd
- What is being tested?
- Inhaled colistin and Inhaled 0.9% sodium chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 444 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged more than or equal to 18 years and less than 80 years
- ABI patients admitted to the ICU, including TBI, intracranial haemorrhage, ischaemic stroke, post-cardiac arrest hypoxic-ischaemic encephalopathy or other acute neurological insults
- Glasgow Coma Scale (GCS) score ≤12
- Duration of mechanical ventilation more than or equal to 48 hours at enrolment
- Written informed consent provided by the participant's legally authorised representative.
Who cannot join
- patients with suspected or confirmed VAP on the day of enrolment
- Anticipated extubation within the next 24 hours.
- Duration of mechanical ventilation exceeding 96 hours prior to enrolment.
- Patients currently receiving or having recently received (within the preceding 24 hours) polymyxin (administered intravenously and/or via nebulization).
- Known hypersensitivity to polymyxin.
- Pregnant or breastfeeding women.
Show all 9Show fewer
- Myasthenia gravis.
- Patient with high risk of death within the first 48h after ICU admission.
- Advanced-stage solid organ malignancy or hematological malignancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China
Nanjing, Jiangsu
Lili Huang, Doctor, +8602583262553, caowangyou007@126.com
Hui Chen, Doctor, +8602583262553, zdywc2012@163.com
About this study
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.
- Being tested
- Inhaled colistin, Inhaled 0.9% sodium chloride
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled colistinDrug
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
Inhaled 0.9% sodium chlorideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Colistin Group | Experimental | 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. Receives: Drug: Inhaled colistin |
| Control Group | Placebo comparator | 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. Receives: Drug: Inhaled 0.9% sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of early VAP
the incidence of VAP within 7 days after randomisation
Measured: From randomization to 7 days
Secondary outcomes (9)
VAP incidence within 28 days
The incidence of VAP within 28 days after randomisation
Measured: 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.
Measured: From randomization to day 28
Success of SBT
The number of days from randomization to the first successful spontaneous breathing test (SBT).
Measured: From randomization to first success of SBT
Invasive ventilator-free days at 28 days
Days alive without endotracheal intubation and invasive mechanical ventilation
Measured: 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.
Measured: From randomization to 28 days
ICU days at day 28
The number of ICU days within 28 days after randomization
Measured: From randomization to 28 days
Hospital days at day 28
The number of Hospital days within 28 days after randomization
Measured: From randomization to 28 days
28-day mortality
The proportion of patients who died within 28 days
Measured: 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.
Measured: From randomization to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start27 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Associated Pneumonia (VAP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819462
- Sponsor's protocol ID
- PREABI-VAP
- Status last verified
- Sep 2026
- First submitted
- 5 Feb 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Colistin to Prevent Ventilator-Associated Pneumonia in Patients With Acute Brain Injury
- ClinicalTrials.gov ID
- NCT06819462
- Acronym / sponsor ID
- PREABI-VAP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 27 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colistin Group | Experimental | Drug: Inhaled colistinNebulization 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. |
| Control Group | Placebo comparator | Drug: Inhaled 0.9% sodium chlorideNebulization 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged more than or equal to 18 years and less than 80 years
- ABI patients admitted to the ICU, including TBI, intracranial haemorrhage, ischaemic stroke, post-cardiac arrest hypoxic-ischaemic encephalopathy or other acute neurological insults
- Glasgow Coma Scale (GCS) score ≤12
- Duration of mechanical ventilation more than or equal to 48 hours at enrolment
- Written informed consent provided by the participant's legally authorised representative.
Key exclusion criteria (9 listed)
- patients with suspected or confirmed VAP on the day of enrolment
- Anticipated extubation within the next 24 hours.
- Duration of mechanical ventilation exceeding 96 hours prior to enrolment.
- Patients currently receiving or having recently received (within the preceding 24 hours) polymyxin (administered intravenously and/or via nebulization).
- Known hypersensitivity to polymyxin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled colistinColistin 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 | Drug | Colistin Group |
| Inhaled 0.9% sodium chlorideSaline 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. | Drug | Control Group |
Primary outcome
Prevention of early VAP
Time frame: From randomization to 7 days
the incidence of VAP within 7 days after randomisation
9 secondary outcomes
VAP incidence within 28 days
Time frame: From randomization to 28 days
Use of systemic antibiotic
Time frame: From randomization to day 28
Success of SBT
Time frame: From randomization to first success of SBT
Invasive ventilator-free days at 28 days
Time frame: From randomization to 28 days
Successful weaning from mechanical ventilation
Time frame: From randomization to 28 days
ICU days at day 28
Time frame: From randomization to 28 days
Hospital days at day 28
Time frame: From randomization to 28 days
28-day mortality
Time frame: From randomization to 28 days
Incidence of AKI
Time frame: From randomization to day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Ventilator-Associated Pneumonia (VAP)
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
Recruiting
Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP
Ventilator Associated Bacterial Pneumonia (VABP), Critical Illness
Active, not recruiting
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia
Ventilator Associated Pneumonia ( VAP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhaled colistin and Inhaled 0.9% sodium chloride in people with Ventilator-Associated Pneumonia (VAP) and Inha'le'd, run by Southeast University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lili Huang, Doctor (+8602583262553, caowangyou007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of early VAP (time frame: From randomization to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.