Back to resultsNebulized Colistin for Hospital-Acquired Pneumonia
Primary Purpose
Pneumonia
Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
nebulized colistin
antibiotics
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia focused on measuring Hospital-Acquired Pneumonia, Gram Negative Bacteria
Eligibility 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
Sites / Locations
- Siriraj Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
antibiotic
colistin group
Arm Description
conventional antibiotics
nebulized colistin
Outcomes
Primary Outcome Measures
Clinical response
Secondary Outcome Measures
Microbiological response and safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00920270
Brief Title
Nebulized Colistin for Hospital-Acquired Pneumonia
Official Title
Efficacy and Safety of Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia Caused by Gram Negative Bacteria
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia caused by Gram Negative Bacteria should be more effective than conventional therapy
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
Hospital-Acquired Pneumonia, Gram Negative Bacteria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
antibiotic
Arm Type
Active Comparator
Arm Description
conventional antibiotics
Arm Title
colistin group
Arm Type
Experimental
Arm Description
nebulized colistin
Intervention Type
Drug
Intervention Name(s)
nebulized colistin
Intervention Description
nebulized colistin 75 mg every 12 hours
Intervention Type
Drug
Intervention Name(s)
antibiotics
Intervention Description
conventional parenteral antibiotics
Primary Outcome Measure Information:
Title
Clinical response
Time Frame
14 days after Treatment
Secondary Outcome Measure Information:
Title
Microbiological response and safety
Time Frame
14 days after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Visanu Thamlikitkul, MD
Organizational Affiliation
Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Nebulized Colistin for Hospital-Acquired Pneumonia
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