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

Bronchitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02619786
• Other study ID #: 512-2558-EC4
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 26, 2015
• Last updated: December 1, 2015
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: November 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchitis

Intervention

Drug:
• Inhaled colistin
75 mg of colistin activity, inhaled per dose, every 12 hours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Cure, Improved, Failure or Death	Clinical outcome is classified in 4 categories: Cure Improved Failure Death	through study completion, an average of 2 weeks	No
Secondary	Number of Patients With Eradication, Persistence or Superinfection	Microbiological response is classified in 4 categories: Eradication Persistence Superinfection	through study completion, an average of 2 weeks	No
Secondary	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.	through study completion, an average of 2 weeks	Yes