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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Hospitales Universitarios Virgen del Rocío.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier:
NCT00645723
First received: March 25, 2008
Last updated: August 3, 2009
Last verified: August 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

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

No publications provided

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
Study First Received: March 25, 2008
Last Updated: August 3, 2009
Health Authority: European Union: European Medicines Agency
Spain: Spanish Agency of Medicines
Spain: Ethics Committee

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

Additional relevant MeSH terms:
Pneumonia, Bacterial
Cross Infection
Pneumonia
Pneumonia, Ventilator-Associated
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Infection
Ventilator-Induced Lung Injury
Lung Injury
Colistin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013