The Effect of Colistin Inhalation on Ventilator Associated Pneumonia

Ventilator Associated Pneumonia Clinical Trial

Official title:

The Effect of Colistin Inhalation on the Clinical Outcome of Patients With Ventilator Associated Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03622450
• Other study ID #: Colistin inhalation form
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2, 2016
• Est. completion date: January 10, 2018

Study information

• Verified date: August 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study has been conducted to measure the clinical outcome of early intervention with colistin inhalation in patients with ventilator associated pneumonia suspected to have multidrug resistant gram -ve bacteria

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 10, 2018
• Est. primary completion date: January 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years

Patients presenting with signs of infection 48 hours of intubation

Exclusion Criteria:

• Patients with documented bronchiectasis

Cystic fibrosis Known allergy to polymyxin. Patients presenting with chest infection or signs of infection before intubation.

Patients with creatinine clearance less than 30ml/min.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Drug:
• Colistin
Polymyxins are bactericidal drugs that bind to lipopolysaccharides (LPS) and phospholipids in the outer cell membrane of gram-negative bacteria.
• Carbapenem + Aminoglycoside/ Quinolone
Dual antipseudomonal given as IV for ventilator associated pneumonia for patients with Multi-drug resistant bacteria risk factors

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan Hassan Osama Thuraya Mohamed	Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Ventilatory status	Pf ratio measurement	7 to 10 days
Secondary	Days of mechanical ventilation	Deescalation in the ventilation mode and trials until successful weaning.	35 Days
Secondary	Time till the occurence of sepsis	long standing ventilator associated pneumonia with failure of treatment can lead to sepsis	35 Days
Secondary	Mortality as an outcome of long stand untreatable ventilator associated pneumonia	is the mortality due to sepsis of other causes	35 days
Secondary	Length of stay in the icu	How long will the patient stay in the ICU according to failure of weaning and progression of the disease.	35 days