Therapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin
1 other identifier
interventional
62
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedDecember 2, 2015
November 1, 2015
1.4 years
November 26, 2015
December 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of Patients With Eradication, Persistence or 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
through study completion, an average of 2 weeks
Study Arms (1)
inhaled colistin
EXPERIMENTALInhaled colistin 75 mg mixed with normal saline up to 4 ml every 12 hours at least 5 days
Interventions
75 mg of colistin activity, inhaled per dose, every 12 hours
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Pregnancy and Lactation
- Allergy to colistin
- Serum creatinine \> 4 mg/dl or GFR decreased more than 75% from baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 20876621BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
November 26, 2015
First Posted
December 2, 2015
Study Start
December 1, 2015
Primary Completion
May 1, 2017
Study Completion
December 1, 2017
Last Updated
December 2, 2015
Record last verified: 2015-11