Inhaled Polymyxin E to Prevent VAP

Launched by SOUTHEAST UNIVERSITY, CHINA · Feb 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of an inhaled antibiotic called Polymyxin E to prevent Ventilator-Associated Pneumonia (VAP) in patients who are on mechanical ventilation in the ICU. VAP is a serious lung infection that can occur in people who need help breathing with a machine, and it can lead to longer hospital stays and increased treatment costs. The researchers are particularly interested in how inhaling this antibiotic might help reduce the chances of developing VAP, especially since patients are most at risk after being on a ventilator for about a week.

To be eligible for the trial, participants need to be over 18 years old, have a brain injury, and require mechanical ventilation for at least 48 hours. They also need to have a specific score that indicates their level of consciousness. However, some people, such as those with certain lung diseases or severe conditions that could lead to death soon, will not be able to participate. If someone joins the study, they can expect to receive either the inhaled antibiotic or a placebo (a treatment with no active ingredient) while being monitored for any changes in their health, particularly regarding the development of pneumonia. This study aims to offer new insights into preventing this serious infection in critically ill patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \>18 years old
• • 2. Patients with brain injury admitted to ICU (including brain injury caused by trauma, cerebral hemorrhage, cerebral infarction, and cardiac arrest)
• • 3. GCS score\<12 points
• • 4. Mechanical ventilation time ≥ 48 hours
• • 5. Sign informed consent
• Exclusion Criteria:
• • 1. Existing lung diseases that require long-term inhaled medication treatment.
• • 2. Lower respiratory tract infection at admission.
• • 3. New or persistent infiltration on chest imaging within 48 hours after admission.
• • 4. Expected removal of endotracheal tube within the next 24 hours.
• • 5. Mechanical ventilation time before enrollment exceeds 96 hours.
• • 6. Tracheostomy patients.
• • 7. Current or recent use of polymyxin E (within 24 hours).
• • 8. Allergy to polymyxin E.
• • 9. Allergic pregnant or lactating women.
• • 10. Severe neuromuscular lesions.
• • 11. Severe other organ dysfunction. Expected short-term death (48 hours) or palliative treatment.
• • 12. Late stage solid organ or blood system tumors. Expected survival\<30 days. 13. Participate in other clinical studies within 30 days