Intravenous Colistin Versus Intravenous Colistin Plus Nebulized Colistin in VAP Due MDR Acinetobacter Baumannii

August 3, 2009 updated by: Hospitales Universitarios Virgen del Rocío

Phase 3b Randomized Double Blind Controled Placebo Comparative Trial of Intravenous Colistin vs Intravenous Colistin Plus Nebulized Colistin in Patients With Ventilator-associated Pneumonia (VAP) Due Multiresistant Acinetobacter Baumanii

Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with VAP due to baumannii carbapenems resistant.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with VAP due to baumannii carbapenems resistant.

Study Type

Interventional

Enrollment (Anticipated)

67

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

  • Spain
      • Seville, Spain, 41008
        • Recruiting
        • Hospital Universitario Virgen Del Rocio
        • Contact:
        • Principal Investigator:
          • José Garnacho, M.D

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:

  • Diagnose of VAP due A. baumannii or A. baumannii and another microorganism carbapenems resistant.
  • Clinical Pulmonary Infection Score (CPIS) > 6

Exclusion Criteria:

  • Allergy to colistin.
  • Asthma
  • Shock status
  • Diagnose of VAP due A. baumannii colistin resistant.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Intravenous colistin and nebulized colistin
Drug: Colistin
intravenous colistin and nebulized colistin
Placebo Comparator: B
intravenous colistin and saline solution nebulized
Drug: Colistin and saline solution
intravenous colistin and nebulized saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with VAP due to baumannii carbapenems resistant
Time Frame: 14 days
14 days

Collaborators and Investigators

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

Sponsor

Hospitales Universitarios Virgen del Rocío

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

April 1, 2008

Primary Completion (Anticipated)

April 1, 2011

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 28, 2008

Study Record Updates

Last Update Posted (Estimate)

August 6, 2009

Last Update Submitted That Met QC Criteria

August 3, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COL\VAP

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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