Therapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin
NCT ID: NCT02619786
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
62 participants
INTERVENTIONAL
2015-12-31
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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inhaled colistin
Inhaled colistin 75 mg mixed with normal saline up to 4 ml every 12 hours at least 5 days
Inhaled colistin
75 mg of colistin activity, inhaled per dose, every 12 hours
Interventions
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Inhaled colistin
75 mg of colistin activity, inhaled per dose, every 12 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Expected to survive more than 48 hours after enrollment.
* Received intravenous colistin not more than 48 hours prior enrollment.
Exclusion Criteria
* Allergy to colistin
* Serum creatinine \> 4 mg/dl or GFR decreased more than 75% from baseline
18 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Adhiratha Boonyasiri
Dr.
References
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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.
Other Identifiers
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512-2558-EC4
Identifier Type: -
Identifier Source: org_study_id