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

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Primary Purpose

Status

Unknown status

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Colistin

Colistin and saline solution

About this trial

This is an interventional treatment trial for Cross Infection focused on measuring Acinetobacter baumanii, Ventilator-associated pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Universitario Virgen del RocíoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Intravenous colistin and nebulized colistin

intravenous colistin and saline solution nebulized

Outcomes

Primary Outcome 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

Secondary Outcome Measures

Full Information

NCT ID

NCT00645723

First Posted

March 25, 2008

Last Updated

August 3, 2009

Sponsor

Hospitales Universitarios Virgen del Rocío

1. Study Identification

Unique Protocol Identification Number

NCT00645723

Brief Title

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

Official Title

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

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Unknown status

Study Start Date

April 2008 (undefined)

Primary Completion Date

April 2011 (Anticipated)

Study Completion Date

April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hospitales Universitarios Virgen del Rocío

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cross Infection, Pneumonia, Bacterial

Keywords

Acinetobacter baumanii, Ventilator-associated pneumonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Experimental

Arm Description

Intravenous colistin and nebulized colistin

Arm Title

B

Arm Type

Placebo Comparator

Arm Description

intravenous colistin and saline solution nebulized

Intervention Type

Drug

Intervention Name(s)

Colistin

Intervention Description

intravenous colistin and nebulized colistin

Intervention Type

Drug

Intervention Name(s)

Colistin and saline solution

Intervention Description

intravenous colistin and nebulized saline solution

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

José Garnacho, MD

Phone

34-95-501-2235

Email

jose.garnacho.sspa@juntadeandalucia.es

Facility Information:

Facility Name

Hospital Universitario Virgen del Rocío

City

Seville

ZIP/Postal Code

41008

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José Garnacho, M.D.

Phone

34-95-501-2235

Email

jose.garnacho.sspa@juntadeandalucia.es

First Name & Middle Initial & Last Name & Degree

José Garnacho, M.D

Cross Infection, Pneumonia, Bacterial

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial