Inhaled Colistin to Prevent Ventilator-Associated Pneumonia in Brain-Injury 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 interventional study explores the use of inhaled colistin, compared with inhaled saline, to prevent pneumonia in adults with acute brain injury who require mechanical ventilation. Eligible participants are adults 18–79 with acute brain injury, a moderate to severe comatose state (GCS ≤ 12), and on mechanical ventilation for at least 48 hours. The intervention is delivered via inhalation and aims to reduce the incidence of ventilator-associated pneumonia by day 7–14 of ventilation, with safety monitoring for antibiotic-related effects. The trial is conducted at a single center in Nanjing, China, led by Southeast University. Results will help determine if early inhaled antibiotic prophylaxis can prevent VAP in this high-risk population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients aged more than or equal to 18 years and less than 80 years
2. ABI patients admitted to the ICU, including TBI, intracranial haemorrhage, ischaemic stroke, post-cardiac arrest hypoxic-ischaemic encephalopathy or other acute neurological insults
3. Glasgow Coma Scale (GCS) score ≤12
4. Duration of mechanical ventilation more than or equal to 48 hours at enrolment
5. Written informed consent provided by the participant's legally authorised representative.

Exclusion Criteria:

1. patients with suspected or confirmed VAP on the day of enrolment
2. Anticipated extubation within the next 24 hours.
3. Duration of mechanical ventilation exceeding 96 hours prior to enrolment.
4. Patients currently receiving or having recently received (within the preceding 24 hours) polymyxin (administered intravenously and/or via nebulization).
5. Known hypersensitivity to polymyxin.
6. Pregnant or breastfeeding women.
7. Myasthenia gravis.
8. Patient with high risk of death within the first 48h after ICU admission.
9. Advanced-stage solid organ malignancy or hematological malignancy.

Where it's running

• Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Lili Huang, Doctor
• Email: caowangyou007@126.com
• Phone: +8602583262553

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

  This study tests whether signs of innate immune immunoparalysis in adults on ventilators are linked to developing ventilator-associated pneumonia (VAP).

  Recruiting Hospital Universitari de Bellvitge · L'Hospitalet de Llobregat, Barcelona · NCT07551258

• Combined mPCR and algorithm-based therapy to optimize early antibiotics in VAP

  This trial tests whether adding a broad respiratory mPCR test and a local-epidemiology algorithm helps doctors choose better initial antibiotics within 24 hours for adults with ventilator-associated pneumonia.

  Recruiting at 2 sites Phase 4 Centre Hospitalier Universitaire de Nīmes · Alès and 1 other locations · NCT07403474

• Using airway resistance changes to guide suctioning for ventilated patients

  This study will test whether monitoring airway viscous resistance from ventilator waveforms can help time sputum suctioning for patients on mechanical ventilation with ARDS, AECOPD, or severe pneumonia.

  Recruiting at 3 sites Affiliated Hospital of Nantong University · Bengbu, Anhui and 2 other locations · NCT07375667

• Two Oral Care Methods for Mechanically Ventilated Adults

  This trial tests whether a pediatric toothbrush or a foam swab for oral care affects oral bacteria and the risk of ventilator-associated pneumonia in adults on mechanical ventilation.

  Recruiting Marmara University · Zonguldak · NCT07283380

• Aztreonam‑avibactam for MBL-producing CRE infections in hospitalized adults

  This study will see if aztreonam‑avibactam helps hospitalized adults with complicated intra‑abdominal infections or hospital/ventilator‑associated pneumonia caused by MBL-producing CRE.

  Recruiting Sir Run Run Shaw Hospital · Nanchang, Jiangxi and 1 other locations · NCT07268560

• 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.

  Recruiting University of Cambridge · Cambridge · NCT07026656

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.