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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
75 mg of colistin activity, inhaled per dose, every 12 hours
Number of Patients With Cure, Improved, Failure or Death
Clinical outcome is classified in 4 categories: Cure Improved Failure Death
Time frame: through study completion, an average of 2 weeks
Number of Patients With Eradication, Persistence or Superinfection
Microbiological response is classified in 4 categories: Eradication Persistence Superinfection
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.