Hospital-Acquired Pneumonia Clinical Trials

Find Hospital-Acquired Pneumonia Clinical Trials Near You

Inhaled Colistin to Prevent Ventilator-Associated Pneumonia in Patients With Acute Brain Injury

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China
RECRUITING
Nanjing
Contact Information
Primary
Lili Huang, Doctor
caowangyou007@126.com
+8602583262553
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 444
Treatments
Experimental: Colistin Group
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.
Placebo_comparator: Control Group
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.
Related Therapeutic Areas
Sponsors
Leads: Southeast University, China

This content was sourced from clinicaltrials.gov