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

NCT ID: NCT00645723

Last Updated: 2009-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-04-30

Brief Summary

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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

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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.

Conditions

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Cross Infection Pneumonia, Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Intravenous colistin and nebulized colistin

Group Type EXPERIMENTAL

Colistin

Intervention Type DRUG

intravenous colistin and nebulized colistin

B

intravenous colistin and saline solution nebulized

Group Type PLACEBO_COMPARATOR

Colistin and saline solution

Intervention Type DRUG

intravenous colistin and nebulized saline solution

Interventions

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Colistin

intravenous colistin and nebulized colistin

Intervention Type DRUG

Colistin and saline solution

intravenous colistin and nebulized saline solution

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospitales Universitarios Virgen del Rocío

OTHER

Sponsor Role lead

Responsible Party

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Servicio de Cuidados Críticos y Urgencias. Hospitales Universitarios Virgen del Rocío

Locations

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Hospital Universitario Virgen del Rocío

Seville, Seville, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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José Garnacho, MD

Role: CONTACT

34-95-501-2235

Facility Contacts

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José Garnacho, M.D.

Role: primary

34-95-501-2235

Other Identifiers

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COL\VAP

Identifier Type: -

Identifier Source: org_study_id

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