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Nebulized Colistin for Hospital-Acquired Pneumonia

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ClinicalTrials.gov Identifier: NCT00920270
Recruitment Status : Unknown
Verified June 2006 by Mahidol University.
Recruitment status was:  Enrolling by invitation
First Posted : June 15, 2009
Last Update Posted : June 15, 2009
Sponsor:
Information provided by:
Mahidol University

Brief Summary:
Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia caused by Gram Negative Bacteria should be more effective than conventional therapy

Condition or disease Intervention/treatment Phase
Pneumonia Drug: nebulized colistin Drug: antibiotics Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
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
Study Start Date : June 2006
Estimated Primary Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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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

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

Responsible Party: Visanu Thamlikitkul, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT00920270     History of Changes
Other Study ID Numbers: Siriraj CEU 50-002
First Posted: June 15, 2009    Key Record Dates
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