Therapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin

Study Overview
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Brief Summary
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The purpose of this study is to determine whether inhaled colistin is effective in the treatment of ventilator associated tracheobronchitis due to gram negative organism susceptible to colistin.

Detailed Description
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Patients diagnosed ventilator-associated tracheobronchitis due to gram negative organism are included to the study.The patients will be received colistin inhalation 75 mg every 12 hours at least 5 days. The primary objective is to evaluate clinical outcome of inhaled colistin. The secondary objectives are microbiological clearance and toxicity of inhaled colistin. The sample size was estimated to 62 patients.

Official Title
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Therapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin

Conditions
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Bronchitis

Intervention / Treatment
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* Drug: Inhaled colistin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of ventilator-associated tracheobronchitis caused by gram negative organism. Expected to survive more than 48 hours after enrollment. Received intravenous colistin not more than 48 hours prior enrollment. Exclusion Criteria: Pregnancy and Lactation Allergy to colistin Serum creatinine > 4 mg/dl or GFR decreased more than 75% from baseline

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inhaled colistin<br>Inhaled colistin 75 mg mixed with normal saline up to 4 ml every 12 hours at least 5 days | Drug: Inhaled colistin<br>* 75 mg of colistin activity, inhaled per dose, every 12 hours<br>* Other names: Colistate 150;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Cure, Improved, Failure or Death | Clinical outcome is classified in 4 categories: Cure Improved Failure Death | through study completion, an average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Eradication, Persistence or Superinfection | Microbiological response is classified in 4 categories: Eradication Persistence Superinfection | through study completion, an average of 2 weeks | 
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0 | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0 focus on neurology and bronchospasm. Nephrotoxicity uses RIFLE criteria for acute kidney injury. RIFLE is an acronym of Risk, Injury, and Failure; and Loss; and End-stage kidney disease. | through study completion, an average of 2 weeks |