Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00645723
NCT00645723
Unknown
Phase 3

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

Hospitales Universitarios Virgen del Rocío1 site in 1 country67 target enrollmentApril 2008
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsCross InfectionPneumonia, Bacterial
InterventionsColistinColistin and saline solution
DrugsColistinColistin and saline solution

Overview

Phase
Phase 3
Intervention
Colistin
Conditions
Cross Infection
Sponsor
Hospitales Universitarios Virgen del Rocío
Enrollment
67
Locations
1
Primary Endpoint
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
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
April 2011
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospitales Universitarios Virgen del Rocío

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

Arms & Interventions

A

Intravenous colistin and nebulized colistin

Intervention: Colistin

B

intravenous colistin and saline solution nebulized

Intervention: Colistin and saline solution

Outcomes

Primary Outcomes

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

Study Sites (1)

Loading locations...

Similar Trials

Terminated
Phase 3
Aerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii in NeonatesPneumonia, Ventilator-AssociatedColistin Adverse ReactionInfection Due to Multidrug Resistant AcinetobacterInfection Resistant to Multiple Drugs
NCT02806141Hat Yai Medical Education Center204
Terminated
Phase 3
A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD)Pulmonary HypertensionChronic Obstructive Pulmonary Disease
NCT03496623United Therapeutics188
Completed
Phase 3
Oral Cladribine in Early Multiple Sclerosis (MS)Multiple Sclerosis
NCT00725985EMD Serono Research & Development Institute, Inc.617
Completed
Phase 3
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial HypercholesterolemiaFamilial Hypercholesterolemia - Heterozygous
NCT04652726Novartis Pharmaceuticals141
Recruiting
Phase 3
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial HypercholesterolemiaFamilial Hypercholesterolemia - Heterozygous
NCT06597019Novartis Pharmaceuticals51