Therapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin
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|ClinicalTrials.gov Identifier: NCT02619786|
Recruitment Status : Unknown
Verified November 2015 by Adhiratha Boonyasiri, Mahidol University.
Recruitment status was: Not yet recruiting
First Posted : December 2, 2015
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bronchitis||Drug: Inhaled colistin||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Therapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: inhaled colistin
Inhaled colistin 75 mg mixed with normal saline up to 4 ml every 12 hours at least 5 days
Drug: Inhaled colistin
75 mg of colistin activity, inhaled per dose, every 12 hours
Other Name: Colistate 150
- Number of Patients With Cure, Improved, Failure or Death [ Time Frame: through study completion, an average of 2 weeks ]
Clinical outcome is classified in 4 categories:
Cure Improved Failure Death
- Number of Patients With Eradication, Persistence or Superinfection [ Time Frame: through study completion, an average of 2 weeks ]
Microbiological response is classified in 4 categories:
Eradication Persistence Superinfection
- 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 [ Time Frame: 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 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.