Nebulized Colistin for Hospital-Acquired Pneumonia

June 11, 2009 updated by: Mahidol University

Efficacy and Safety of Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia Caused by Gram Negative Bacteria

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical response
Time Frame: 14 days after Treatment
14 days after Treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Microbiological response and safety
Time Frame: 14 days after treatment
14 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

June 11, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (Estimate)

June 15, 2009

Study Record Updates

Last Update Posted (Estimate)

June 15, 2009

Last Update Submitted That Met QC Criteria

June 11, 2009

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Siriraj CEU 50-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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