Back to resultsTherapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin
Primary Purpose
Bronchitis
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Inhaled colistin
Sponsored by
About this trial
This is an interventional treatment trial for Bronchitis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
inhaled colistin
Arm Description
Inhaled colistin 75 mg mixed with normal saline up to 4 ml every 12 hours at least 5 days
Outcomes
Primary Outcome Measures
Number of Patients With Cure, Improved, Failure or Death
Clinical outcome is classified in 4 categories:
Cure Improved Failure Death
Secondary Outcome Measures
Number of Patients With Eradication, Persistence or Superinfection
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02619786
Brief Title
Therapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin
Official Title
Therapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
inhaled colistin
Arm Type
Experimental
Arm Description
Inhaled colistin 75 mg mixed with normal saline up to 4 ml every 12 hours at least 5 days
Intervention Type
Drug
Intervention Name(s)
Inhaled colistin
Other Intervention Name(s)
Colistate 150
Intervention Description
75 mg of colistin activity, inhaled per dose, every 12 hours
Primary Outcome Measure Information:
Title
Number of Patients With Cure, Improved, Failure or Death
Description
Clinical outcome is classified in 4 categories:
Cure Improved Failure Death
Time Frame
through study completion, an average of 2 weeks
Secondary Outcome Measure Information:
Title
Number of Patients With Eradication, Persistence or Superinfection
Description
Microbiological response is classified in 4 categories:
Eradication Persistence Superinfection
Time Frame
through study completion, an average of 2 weeks
Title
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
Description
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.
Time Frame
through study completion, an average of 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
20876621
Citation
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.
Results Reference
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Therapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin
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