Therapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin
Overview
- Phase
- Phase 3
- Intervention
- Inhaled colistin
- Conditions
- Bronchitis
- Sponsor
- Mahidol University
- Enrollment
- 62
- Primary Endpoint
- Number of Patients With Cure, Improved, Failure or Death
- Last Updated
- 10 years ago
Overview
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.
Investigators
Adhiratha Boonyasiri
Dr.
Mahidol University
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
Arms & Interventions
inhaled colistin
Inhaled colistin 75 mg mixed with normal saline up to 4 ml every 12 hours at least 5 days
Intervention: Inhaled colistin
Outcomes
Primary Outcomes
Number of Patients With Cure, Improved, Failure or Death
Time Frame: through study completion, an average of 2 weeks
Clinical outcome is classified in 4 categories: Cure Improved Failure Death
Secondary Outcomes
- 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)