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

Study Overview
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Brief Summary
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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.

Detailed Description
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When a patient will present a suspicion of VAP (Clinical Pulmonary Infection Score modified ≥ 5), Simvastatin or placebo will be administered with antibiotics. Quantitative cultures will be performed for microbiological confirmation of VAP. Simvastatin or placebo will be administered through an enteral feeding tube or administered orally when patients are able to safely take oral medications. The type and placement of the enteral feeding tube (nasogastric, nasoenteric, PEG, orogastric, oroenteric, etc.) and the ability to safely take oral medications will be determined by the patient's primary team. Study drug will be blinded with an identical appearing placebo. Sequential Organ Failure Assessment score (SOFA), and various blood factors will be measured during treatment.

Official Title
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Effect of the Association of a Statin to Antibiotics on the Prognosis of Patients Presenting With a Suspicion of Ventilator-associated Pneumonia

Conditions
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Pneumonia

Intervention / Treatment
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* Drug: SIMVASTATIN
* Drug: PLACEBO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PLACEBO<br>Half of the patients will be randomized to the placebo | Drug: PLACEBO<br>* Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study ICU<br>|
| Active Comparator: Simvastatin<br>Half of the subjects will receive the active drug, Simvastatin. | Drug: SIMVASTATIN<br>* Patients will receive 60 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study ICU.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary efficacy measure is hospital mortality to day 28. |  | 28 days after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suspicion of ventilator-associated pneumonia