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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 2011

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.

Interventions

  • Drug: Colistin
    • intravenous colistin and nebulized colistin
  • Drug: Colistin and saline solution
    • intravenous colistin and nebulized saline solution

Arms, Groups and Cohorts

  • Experimental: A
    • Intravenous colistin and nebulized colistin
  • Placebo Comparator: B
    • intravenous colistin and saline solution nebulized

Clinical Trial Outcome Measures

Primary 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospitales Universitarios Virgen del Rocío
  • Provider of Information About this Clinical Study
    • JOSÉ GARNACHO MONTERO, Servicio de Cuidados Críticos y Urgencias. Hospitales Universitarios Virgen del Rocío
  • Overall Contact(s)
    • José Garnacho, MD, 34-95-501-2235, jose.garnacho.sspa@juntadeandalucia.es

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