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Nebulized Colistin for Hospital-Acquired Pneumonia

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00920270
First received: June 11, 2009
Last updated: NA
Last verified: June 2006
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Clinical response [ Time Frame: 14 days after Treatment ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920270

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

No publications provided

Responsible Party: Visanu Thamlikitkul, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT00920270     History of Changes
Other Study ID Numbers: Siriraj CEU 50-002
Study First Received: June 11, 2009
Last Updated: June 11, 2009
Health Authority: Thailand: Ethical Committee

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
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013