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

• Sponsor: Hospitales Universitarios Virgen del Rocío (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00645723
• Collaborator: (none)
• Enrollment: 67
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cross Infection; Pneumonia, Bacterial	Drug: Colistin; Drug: Colistin and saline solution	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Apr 1, 2008
• Anticipated Primary Completion Date: Apr 1, 2011
• Anticipated Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Intravenous colistin and nebulized colistin	Drug: Colistin; intravenous colistin and nebulized colistin
Placebo Comparator: B intravenous colistin and saline solution nebulized	Drug: Colistin and saline solution; intravenous colistin and nebulized saline solution

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Virgen del Rocío	Seville		Spain	41008

Sponsors and Collaborators

• Hospitales Universitarios Virgen del Rocío

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00645723
• Other Study ID Numbers: COL\VAP
• First Posted: Mar 28, 2008
• Last Update Posted: Aug 6, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: Acinetobacter baumanii; Ventilator-associated pneumonia
• Additional relevant MeSH terms: Pneumonia; Pneumonia, Bacterial; Cross Infection; Colistin

Study Results

No Results Posted as of Aug 6, 2009