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

March 25, 2008
August 3, 2009
April 2008
April 2011   (final data collection date for primary outcome measure)
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 ]
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 [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00645723 on ClinicalTrials.gov Archive Site
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Intravenous Colistin Versus Intravenous Colistin Plus Nebulized Colistin in VAP Due MDR Acinetobacter Baumannii
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Cross Infection
  • Pneumonia, Bacterial
  • Drug: Colistin
    intravenous colistin and nebulized colistin
  • Drug: Colistin and saline solution
    intravenous colistin and nebulized saline solution
  • Experimental: A
    Intravenous colistin and nebulized colistin
    Intervention: Drug: Colistin
  • Placebo Comparator: B
    intravenous colistin and saline solution nebulized
    Intervention: Drug: Colistin and saline solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
67
April 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: José Garnacho, MD 34-95-501-2235 jose.garnacho.sspa@juntadeandalucia.es
Spain
 
NCT00645723
COL\VAP
Yes
JOSÉ GARNACHO MONTERO, Servicio de Cuidados Críticos y Urgencias. Hospitales Universitarios Virgen del Rocío
Hospitales Universitarios Virgen del Rocío
Not Provided
Not Provided
Hospitales Universitarios Virgen del Rocío
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP