NCT00645723

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
67

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

August 6, 2009

Status Verified

August 1, 2009

Enrollment Period

3 years

First QC Date

March 25, 2008

Last Update Submit

August 3, 2009

Conditions

Cross InfectionPneumonia, Bacterial

Keywords

Acinetobacter baumaniiVentilator-associated pneumonia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

A

EXPERIMENTAL

Intravenous colistin and nebulized colistin

Drug: Colistin

B

PLACEBO COMPARATOR

intravenous colistin and saline solution nebulized

Drug: Colistin and saline solution

Interventions

ColistinDRUG

intravenous colistin and nebulized colistin

A
Colistin and saline solutionDRUG

intravenous colistin and nebulized saline solution

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnose of VAP due A. baumannii or A. baumannii and another microorganism carbapenems resistant.
  • Clinical Pulmonary Infection Score (CPIS) \> 6

You may not qualify if:

  • Allergy to colistin.
  • Asthma
  • Shock status
  • Diagnose of VAP due A. baumannii colistin resistant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, Seville, 41008, Spain

RECRUITING

MeSH Terms

Conditions

Cross InfectionPneumonia, BacterialPneumonia, Ventilator-Associated

Interventions

ColistinSaline Solution

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial InfectionsBacterial Infections and MycosesPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesHealthcare-Associated Pneumonia

Intervention Hierarchy (Ancestors)

PolymyxinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsAntimicrobial Cationic PeptidesPeptidesAmino Acids, Peptides, and ProteinsAntimicrobial PeptidesPore Forming Cytotoxic ProteinsMembrane ProteinsProteinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

José Garnacho, MD

CONTACT

34-95-501-2235jose.garnacho.sspa@juntadeandalucia.es

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 28, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

August 6, 2009

Record last verified: 2009-08

Locations

ES(1)