Pravastatin and Ventilatory Associated Pneumonia (EPRAVAP)
![]() |
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. |
ClinicalTrials.gov Identifier: NCT00702130 |
Recruitment Status :
Completed
First Posted : June 20, 2008
Last Update Posted : November 30, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Ventilator Associated Pneumonia | Drug: Pravastatin | Early Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 152 participants |
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 |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | April 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: A
this arm will receive Pravastatin 40 mg per os daily
|
Drug: Pravastatin
pravastatin 40mg per os once daily |
No Intervention: 1 |
- Length of hospitalization in the Intensive Care Unit, morbidity in the Intensive Care Unit [ Time Frame: 1 year ]
- Severity of Ventilator Associated Pneumonia [ Time Frame: 1 year ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 14 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

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
Greece | |
General Hospital Larissa | |
Larissa, Thessalia, Greece, 41221 | |
Zakynthinos E. Dir-University Hospital Larisa | |
Mezourlo / Larissa, Greece, 41110 |
Responsible Party: | Efstratios Manoulakas, Ph, University of Thessaly |
ClinicalTrials.gov Identifier: | NCT00702130 |
Other Study ID Numbers: |
310UT |
First Posted: | June 20, 2008 Key Record Dates |
Last Update Posted: | November 30, 2011 |
Last Verified: | November 2011 |
Ventilator Associated Pneumonia |
Pneumonia, Ventilator-Associated Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Cross Infection Infection Pravastatin |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |