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

This study is not yet open for participant recruitment.
Verified November 2015 by Adhiratha Boonyasiri, Mahidol University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02619786
First Posted: December 2, 2015
Last Update Posted: December 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Adhiratha Boonyasiri, Mahidol University
  Purpose
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.

Condition Intervention Phase
Bronchitis Drug: Inhaled colistin Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin

Resource links provided by NLM:


Further study details as provided by Adhiratha Boonyasiri, Mahidol University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Number of Patients With Eradication, Persistence or Superinfection [ Time Frame: 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 [ 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 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.


Estimated Enrollment: 62
Study Start Date: December 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: inhaled colistin
Inhaled colistin 75 mg mixed with normal saline up to 4 ml every 12 hours at least 5 days
Drug: Inhaled colistin
75 mg of colistin activity, inhaled per dose, every 12 hours
Other Name: Colistate 150

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Adhiratha Boonyasiri, Dr., Mahidol University
ClinicalTrials.gov Identifier: NCT02619786     History of Changes
Other Study ID Numbers: 512-2558-EC4
First Submitted: November 26, 2015
First Posted: December 2, 2015
Last Update Posted: December 2, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Colistin
Anti-Bacterial Agents
Anti-Infective Agents