Pravastatin and Ventilatory Associated Pneumonia

NCT00702130 | Completed Early Phase 1 DMC

• 1 other identifier: 310UT
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Ventilator Associated Pneumonia

Keywords

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• Length of hospitalization in the Intensive Care Unit, morbidity in the Intensive Care Unit

  1 year

Secondary Outcomes (1)

• Severity of Ventilator Associated Pneumonia

  1 year

Study Arms (2)

A

EXPERIMENTAL

this arm will receive Pravastatin 40 mg per os daily

Drug: Pravastatin

1

NO INTERVENTION

Interventions

Pravastatin DRUG

pravastatin 40mg per os once daily

A

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence in Intensive Care Unit

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (2)

General Hospital Larissa

Larissa, Thessaly, 41221, Greece

Location

Zakynthinos E. Dir-University Hospital Larisa

Mezourlo / Larissa, 41110, Greece

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Pravastatin

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 20, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: November 30, 2011

Record last verified: 2011-11

Locations

GR (2)