Pravastatin and Ventilator Associated Pneumonia - Full Text View

Sponsored by:	University of Thessaly
Information provided by:	University of Thessaly
ClinicalTrials.gov Identifier:	NCT00702130

Purpose

The use of pravastatin reduces the incidence of Ventilator Associated Pneumonia in the ICU and is related with favorable outcome of patients with Ventilator Associated Pneumonia

Condition	Intervention	Phase
Ventilator Associated Pneumonia	Drug: Pravastatin	Phase 0

MedlinePlus related topics: Pneumonia

Drug Information available for: Pravastatin Pravastatin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Pravastatin on the Incidence and in the Natural Course of Ventilatory Associated Pneumonia in the Intensive Care Unit Patients

Further study details as provided by University of Thessaly:

Primary Outcome Measures:

Length of hospitalization in the Intensive Care Unit, morbidity in the Intensive Care Unit [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Severity of Ventilator Associated Pneumonia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Pravastatin	Drug: Pravastatin pravastatin 40mg per os once daily
1: No Intervention

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Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Presence in Intensive Care Unit

Exclusion Criteria:

Pregnancy,
Pneumonia, previous use of statins,
Contraindications to statin use (liver dysfunction, SGOT/SGPT > 100 U/L),
Increased CPK (over 3 times the upper limit) on admission,
Increase of CPK (over 5 times the upper limit) during hospitalization,
Use of substances that contraindicates simultaneous use of statins (macrolides, cyclosporine, antipyrin, cholestyramine, cholestepol, gemfibrosil, warfarin),
Malabsorption syndrome (over the first 48 hours).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702130

Locations

Greece
Zakynthinos E. Dir-University Hospital Larisa	Recruiting
Mezourlo / Larissa, Greece, 41110
Contact: Epaminondas Zakinthynos, Professor 00302410681240
Greece, THESSALIA
General Hospital Larissa	Recruiting
LARISSA, THESSALIA, Greece, 41221
Contact: Apostolos Komnos, Director 00302410532787

Sponsors and Collaborators

University of Thessaly

More Information

Responsible Party:	Intensive Care Unit department University Hospital Larisa ( Zakynthinos E )
Study ID Numbers:	310UT
Study First Received:	June 19, 2008
Last Updated:	July 2, 2008
ClinicalTrials.gov Identifier:	NCT00702130
Health Authority:	Greece: Ethics Committee

Keywords provided by University of Thessaly:

Ventilator Associated Pneumonia

Study placed in the following topic categories:

Pravastatin
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases

Pneumonia, Ventilator-Associated
Cross Infection
Pneumonia

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009