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The Effect of Colistin Inhalation on Ventilator Associated Pneumonia

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03622450
Enrollment
40
Registered
2018-08-09
Start date
2016-01-02
Completion date
2018-01-10
Last updated
2018-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia

Brief 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

Interventions

DRUGColistin

Polymyxins are bactericidal drugs that bind to lipopolysaccharides (LPS) and phospholipids in the outer cell membrane of gram-negative bacteria.

DRUGCarbapenem + Aminoglycoside/ Quinolone

Dual antipseudomonal given as IV for ventilator associated pneumonia for patients with Multi-drug resistant bacteria risk factors

Sponsors

Ain Shams University
CollaboratorOTHER
Nourhan Hassan Osama Thuraya Mohamed
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Ventilatory status7 to 10 daysPf ratio measurement

Secondary

MeasureTime frameDescription
Days of mechanical ventilation35 DaysDeescalation in the ventilation mode and trials until successful weaning.
Time till the occurence of sepsis35 Dayslong standing ventilator associated pneumonia with failure of treatment can lead to sepsis
Mortality as an outcome of long stand untreatable ventilator associated pneumonia35 daysis the mortality due to sepsis of other causes
Length of stay in the icu35 daysHow long will the patient stay in the ICU according to failure of weaning and progression of the disease.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026