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Nebulized Colistin for Hospital-Acquired Pneumonia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2006 by Mahidol University.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00920270
First Posted: June 15, 2009
Last Update Posted: June 15, 2009
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. Read our disclaimer for details.
Information provided by:
Mahidol University
  Purpose
Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia caused by Gram Negative Bacteria should be more effective than conventional therapy

Condition Intervention Phase
Pneumonia Drug: nebulized colistin Drug: antibiotics Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia Caused by Gram Negative Bacteria

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Clinical response [ Time Frame: 14 days after Treatment ]

Secondary Outcome Measures:
  • Microbiological response and safety [ Time Frame: 14 days after treatment ]

Estimated Enrollment: 140
Study Start Date: June 2006
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: antibiotic
conventional antibiotics
Drug: antibiotics
conventional parenteral antibiotics
Experimental: colistin group
nebulized colistin
Drug: nebulized colistin
nebulized colistin 75 mg every 12 hours

Detailed Description:
Randomized Controlled Clinical Trial in hospitalized adult patients with hospital-acquired pneumonia. The patients are allocated to conventional group or nebulized colistin group. The conventional group receives conventional antibiotics whereas the nebulized colistin group receives nebulized colistin in addition to conventional antibiotics. The outcomes are clinical response and microbiological responses.
  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:

  • Adult (age>18 years) hospitalized patient with hospital-acquired pneumonia due to Gram negative bacteria

Exclusion Criteria:

  • pregnancy
  • lactating woman
  • colistin allergy
  • severe renal impairment
  • epilepsy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00920270


Locations
Thailand
Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Visanu Thamlikitkul, MD Siriraj Hospital
  More Information

Responsible Party: Visanu Thamlikitkul, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT00920270     History of Changes
Other Study ID Numbers: Siriraj CEU 50-002
First Submitted: June 11, 2009
First Posted: June 15, 2009
Last Update Posted: June 15, 2009
Last Verified: June 2006

Keywords provided by Mahidol University:
Hospital-Acquired Pneumonia
Gram Negative Bacteria

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Colistin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents