Bronchitis
Conditions
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.
Interventions
DRUGInhaled colistin
75 mg of colistin activity, inhaled per dose, every 12 hours
Sponsors
Mahidol University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Cure, Improved, Failure or Death | through study completion, an average of 2 weeks | Clinical outcome is classified in 4 categories: Cure Improved Failure Death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Eradication, Persistence or Superinfection | 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 | 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. |
Outcome results
None listed