We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Hospitales Universitarios Virgen del Rocío.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00645723
First Posted: March 28, 2008
Last Update Posted: August 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospitales Universitarios Virgen del Rocío
  Purpose
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.

Condition Intervention Phase
Cross Infection Pneumonia, Bacterial Drug: Colistin Drug: Colistin and saline solution Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hospitales Universitarios Virgen del Rocío:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 67
Study Start Date: April 2008
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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): NCT00645723


Contacts
Contact: José Garnacho, MD 34-95-501-2235 jose.garnacho.sspa@juntadeandalucia.es

Locations
Spain
Hospital Universitario Virgen del Rocío Recruiting
Seville, Spain, 41008
Contact: José Garnacho, M.D.    34-95-501-2235    jose.garnacho.sspa@juntadeandalucia.es   
Principal Investigator: José Garnacho, M.D         
Sponsors and Collaborators
Hospitales Universitarios Virgen del Rocío
  More Information

Responsible Party: JOSÉ GARNACHO MONTERO, Servicio de Cuidados Críticos y Urgencias. Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier: NCT00645723     History of Changes
Other Study ID Numbers: COL\VAP
First Submitted: March 25, 2008
First Posted: March 28, 2008
Last Update Posted: August 6, 2009
Last Verified: August 2009

Keywords provided by Hospitales Universitarios Virgen del Rocío:
Acinetobacter baumanii
Ventilator-associated pneumonia

Additional relevant MeSH terms:
Pneumonia, Bacterial
Pneumonia
Pneumonia, Ventilator-Associated
Cross Infection
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Ventilator-Induced Lung Injury
Lung Injury
Bacterial Infections
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Pharmaceutical Solutions
Colistin
Anti-Bacterial Agents
Anti-Infective Agents