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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| inhaled colistin | Experimental | Inhaled colistin 75 mg mixed with normal saline up to 4 ml every 12 hours at least 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled colistin | Drug | 75 mg of colistin activity, inhaled per dose, every 12 hours |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20876621 | Background | Rattanaumpawan P, Lorsutthitham J, Ungprasert P, Angkasekwinai N, Thamlikitkul V. Randomized controlled trial of nebulized colistimethate sodium as adjunctive therapy of ventilator-associated pneumonia caused by Gram-negative bacteria. J Antimicrob Chemother. 2010 Dec;65(12):2645-9. doi: 10.1093/jac/dkq360. Epub 2010 Sep 28. |
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| ID | Term |
|---|---|
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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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 |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |