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

Phase 3

• Conditions: Cross Infection; Pneumonia, Bacterial
• Interventions: Drug: Colistin and saline solution; Drug: Colistin

• Registration Number: NCT00645723
• Lead Sponsor: Hospitales Universitarios Virgen del Rocío

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-28
• Study Start: 2008-04
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-03
• Last Update Posted: 2009-08-06
• Primary Completion: 2011-04
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Colistin and saline solution	intravenous colistin and saline solution nebulized
A	Colistin	Intravenous colistin and nebulized colistin

Primary Outcome Measures

Name	Time	Method
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	14 days

Trial Locations

Locations (1)

Hospital Universitario Virgen del Rocío; 🇪🇸 Seville, Spain