The Effect of Colistin Inhalation on Ventilator Associated Pneumonia

Study Overview
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Brief Summary
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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

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

Conditions
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Ventilator Associated Pneumonia

Intervention / Treatment
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* Drug: Colistin
* Drug: Carbapenem + Aminoglycoside/ Quinolone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication arm<br>Colistin to be given as 2 millions three times daily in the inhalation form from 5 to 7 days in addition to another antipseudomonal antibiotic according to infectious disease society of antimicrobials (IDSA) guidelines from day 1 of incidence of ventilator associated pneumonia | Drug: Colistin<br>* Polymyxins are bactericidal drugs that bind to lipopolysaccharides (LPS) and phospholipids in the outer cell membrane of gram-negative bacteria.<br>* Other names: Colomycin;|
| Active Comparator: Control arm<br>Patients receive antipseudomonal antibiotics IV as carbapenem and quinolone or aminoglycoside according to IDSA guidelines from day 1 of incidence of Ventilator associated pneumonia carbapenem as 1g three times daily + tavanic 750mg once daily or ciprofloxacin 500mg twice daily or aminoglycoside according to renal function | Drug: Carbapenem + Aminoglycoside/ Quinolone<br>* Dual antipseudomonal given as IV for ventilator associated pneumonia for patients with Multi-drug resistant bacteria risk factors<br>* Other names: tienam,meropenem,levofloxacin,ciprofloxacin,amikacin,gentamicin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Ventilatory status | Pf ratio measurement | 7 to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of mechanical ventilation | Deescalation in the ventilation mode and trials until successful weaning. | 35 Days | 
| Time till the occurence of sepsis | long standing ventilator associated pneumonia with failure of treatment can lead to sepsis | 35 Days | 
| Mortality as an outcome of long stand untreatable ventilator associated pneumonia | is the mortality due to sepsis of other causes | 35 days | 
| 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 |