Therapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin

Phase 3

• Conditions: Bronchitis
• Interventions: Drug: Inhaled colistin

• Registration Number: NCT02619786
• Lead Sponsor: Mahidol University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2015-11
• Study First Submitted: 2015-11-26
• Study Start: 2015-12
• Study First Submitted QC: 2015-12-01
• Last Update Submitted: 2015-12-01
• Study First Posted: 2015-12-02
• Last Update Posted: 2015-12-02
• Primary Completion: 2017-05
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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.

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Exclusion Criteria

• Pregnancy and Lactation
• Allergy to colistin
• Serum creatinine > 4 mg/dl or GFR decreased more than 75% from baseline

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
inhaled colistin	Inhaled colistin	Inhaled colistin 75 mg mixed with normal saline up to 4 ml every 12 hours at least 5 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.