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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