STATIN-VAP STATIN-VAP - STATINs and Ventilator-Associated Pneumonia

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective is to assess the efficacy and safety of oral simvastatin in patients with a suspicion of ventilator-associated pneumonia (VAP). The hypothesis of this study is that simvastatin therapy will improve mortality in patients a suspicion of VAP.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique Hopitaux De Marseille
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• Duration of mechanical ventilation > 48 h

• First episode of suspicion of VAP with a Clinical Pulmonary Infection Score modified ≥ 5

• BAL, plugged telescopic catheter and/or tracheal aspirates quantitative cultures performed prior administration of antibiotics

• Informed consent

Exclusion Criteria:

• Statin treatment received under mechanical ventilation

• Age less than 18 years

• Pregnancy

• Unable to receive or unlikely to absorb enteral study drug

• Patient, surrogate, or physician not committed to full support ).

• Moribund patient with a SAPS II score > 75

• Simvastatin specific exclusions Allergy or intolerance to statins Physician insistence for the use or avoidance of statins during the current hospitalization CK , ALT or AST > 5 times the upper limit of normal Receiving cyclosporine, gemfibrozil, lopinavir, ritonavir itraconazole, kétoconazole, érythromycine, clarithromycine, télithromycine, néfazodone, verapamil, diltiazem

• Severe chronic liver disease