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Pravastatin and Ventilatory Associated Pneumonia (EPRAVAP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00702130
First Posted: June 20, 2008
Last Update Posted: November 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Efstratios Manoulakas, University of Thessaly
  Purpose

Statins present anti-inflammatory and immunomodulatory effects. They may modify the regulation of cytokines, (released from the cellular damage) and may reduce the production of C-reactive protein levels. It has been hypothesized that these pleiotropic characteristic of statins might be useful in the management of various diseases, including pneumonia. Indeed, a recent study showed that statin treatment is associated with reduced risk of pneumonia in diabetic patients. However, the relationship between statins and reduced risk of pneumonia is not consistent . In addition there is no prospective study to investigate the role of statins in severe forms of pneumonia such as the VAP.

On this base the investigators aim to study prospectively the effect of statins on the outcome of patients with VAP in the ICU settings. The investigators therefore contacted a double open label randomized trial to investigate whether the use of pravastatin reduces the incidence of Ventilator Associated Pneumonia in the ICU and whether it is related with favorable outcome of patients with Ventilator Associated Pneumonia.


Condition Intervention Phase
Ventilator Associated Pneumonia Drug: Pravastatin Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Pravastatin on the Incidence and in the Natural Course of Ventilatory Associated Pneumonia in the Intensive Care Unit Patients

Resource links provided by NLM:


Further study details as provided by Efstratios Manoulakas, University of Thessaly:

Primary Outcome Measures:
  • Length of hospitalization in the Intensive Care Unit, morbidity in the Intensive Care Unit [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Severity of Ventilator Associated Pneumonia [ Time Frame: 1 year ]

Enrollment: 152
Study Start Date: June 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
this arm will receive Pravastatin 40 mg per os daily
Drug: Pravastatin
pravastatin 40mg per os once daily
No Intervention: 1

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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), (for non trauma patients) 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, gemfibrosil, warfarin),
  • Malabsorption syndrome (over the first 48 hours).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00702130


Locations
Greece
General Hospital Larissa
Larissa, Thessalia, Greece, 41221
Zakynthinos E. Dir-University Hospital Larisa
Mezourlo / Larissa, Greece, 41110
Sponsors and Collaborators
University of Thessaly
  More Information

Responsible Party: Efstratios Manoulakas, Ph, University of Thessaly
ClinicalTrials.gov Identifier: NCT00702130     History of Changes
Other Study ID Numbers: 310UT
First Submitted: June 19, 2008
First Posted: June 20, 2008
Last Update Posted: November 30, 2011
Last Verified: November 2011

Keywords provided by Efstratios Manoulakas, University of Thessaly:
Ventilator Associated Pneumonia

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors